NDC Code(s) : 0941-0411-05, 0941-0411-06, 0941-0411-07, 0941-0411-04, 0941-0411-11, 0941-0413-05, 0941-0413-06, 0941-0413-07, 0941-0413-01, 0941-0413-04, 0941-0415-05, 0941-0415-06, 0941-0415-04, 0941-0415-07, 0941-0415-01, 0941-0409-06, 0941-0409-05, 0941-0409-07, 0941-0409-01, 0941-0457-08, 0941-0457-02, 0941-0457-05, 0941-0457-01, 0941-0459-08, 0941-0459-02, 0941-0459-05, 0941-0459-01, 0941-0426-52, 0941-0426-53, 0941-0426-55, 0941-0427-52, 0941-0427-53, 0941-0427-55, 0941-0429-52, 0941-0429-53, 0941-0429-55, 0941-0424-51, 0941-0424-52, 0941-0424-53, 0941-0424-55, 0941-0430-51, 0941-0430-52, 0941-0430-53, 0941-0430-55, 0941-0433-51, 0941-0433-52, 0941-0433-53, 0941-0433-55, 0941-0484-01, 0941-0487-01, 0941-0490-01
Packager : Baxter Healthcare Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0411
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE1.5 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE25.7 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0411-051000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
2NDC:0941-0411-062000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
3NDC:0941-0411-075000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
4NDC:0941-0411-043000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
5NDC:0941-0411-116000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 09/27/1978
DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0413
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE2.5 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE25.7 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0413-051000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
2NDC:0941-0413-062000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
3NDC:0941-0413-075000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
4NDC:0941-0413-016000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
5NDC:0941-0413-043000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 09/27/1978
DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0415
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE4.25 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE25.7 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0415-051000 mL in 1 BAG Type 0: Not a Combination Product28/09/1978
2NDC:0941-0415-062000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
3NDC:0941-0415-043000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
4NDC:0941-0415-075000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
5NDC:0941-0415-016000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 09/27/1978
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0409
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE1.5 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE18.3 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0409-062000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
2NDC:0941-0409-053000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
3NDC:0941-0409-075000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
4NDC:0941-0409-016000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 09/27/1978
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0457
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE2.5 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE18.3 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0457-082000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
2NDC:0941-0457-023000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
3NDC:0941-0457-055000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
4NDC:0941-0457-016000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 09/27/1978
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0459
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE4.25 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE18.3 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0459-082000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
2NDC:0941-0459-023000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
3NDC:0941-0459-055000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
4NDC:0941-0459-016000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 09/27/1978
DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0426
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE1.5 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE25.7 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0426-522000 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
2NDC:0941-0426-532500 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
3NDC:0941-0426-553000 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020163 12/04/1992
DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0427
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE2.5 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE25.7 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0427-522000 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
2NDC:0941-0427-532500 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
3NDC:0941-0427-553000 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020163 12/04/1992
DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0429
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE4.25 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE25.7 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0429-522000 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
2NDC:0941-0429-532500 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
3NDC:0941-0429-553000 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020163 12/04/1992
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0424
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE1.5 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE18.3 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0424-511500 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
2NDC:0941-0424-522000 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
3NDC:0941-0424-532500 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
4NDC:0941-0424-553000 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020183 12/04/1992
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0430
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE2.5 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE18.3 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0430-511500 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
2NDC:0941-0430-522000 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
3NDC:0941-0430-532500 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
4NDC:0941-0430-553000 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020183 12/04/1992
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0433
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE4.25 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(LACTIC ACID - UNII:33X04XA5AT) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE18.3 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0433-511500 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
2NDC:0941-0433-522000 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
3NDC:0941-0433-532500 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
4NDC:0941-0433-553000 mL in 1 BAG Type 0: Not a Combination Product12/04/1992
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020183 12/04/1992
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0484
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE1.5 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(SODIUM CATION - UNII:LYR4M0NH37) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM CHLORIDE18.4 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0484-015000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 09/27/1978
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0487
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE2.5 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(SODIUM CATION - UNII:LYR4M0NH37) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE18.4 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0487-015000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 09/27/1978
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0490
Route of Administration INTRAPERITONEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE4.25 g in 100 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE538 mg in 100 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)
(SODIUM CATION - UNII:LYR4M0NH37) 		SODIUM LACTATE448 mg in 100 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE18.4 mg in 100 mL
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
(CHLORIDE ION - UNII:Q32ZN48698) 		MAGNESIUM CHLORIDE5.08 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0941-0490-015000 mL in 1 BAG Type 0: Not a Combination Product27/09/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 09/27/1978

LABELER - Baxter Healthcare Corporation(005083209)

Establishment
Name Address ID/FEI Business Operations
Baxter Healthcare Corporation 059140764 ANALYSIS(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433), MANUFACTURE(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433), LABEL(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433), PACK(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433), STERILIZE(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433), API MANUFACTURE(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433)

Establishment
Name Address ID/FEI Business Operations
Baxter Healthcare Corporation 194684502 ANALYSIS(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433)

Establishment
Name Address ID/FEI Business Operations
Baxter, S.A. de C.V. 810432484 ANALYSIS(0941-0409, 0941-0457, 0941-0411, 0941-0413), MANUFACTURE(0941-0409, 0941-0457, 0941-0411, 0941-0413), LABEL(0941-0409, 0941-0457, 0941-0411, 0941-0413), PACK(0941-0409, 0941-0457, 0941-0411, 0941-0413), STERILIZE(0941-0409, 0941-0457, 0941-0411, 0941-0413), API MANUFACTURE(0941-0409, 0941-0457, 0941-0411, 0941-0413)

Establishment
Name Address ID/FEI Business Operations
Baxter Healthcare S.A. 988899845 ANALYSIS(0941-0484, 0941-0487, 0941-0490), MANUFACTURE(0941-0484, 0941-0487, 0941-0490), LABEL(0941-0484, 0941-0487, 0941-0490), PACK(0941-0484, 0941-0487, 0941-0490), STERILIZE(0941-0484, 0941-0487, 0941-0490)

Establishment
Name Address ID/FEI Business Operations
Baxter SA 370353835 ANALYSIS(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433)

Establishment
Name Address ID/FEI Business Operations
Baxter Healthcare Corporation 189326168 ANALYSIS(0941-0424, 0941-0430), MANUFACTURE(0941-0424, 0941-0430), LABEL(0941-0424, 0941-0430), PACK(0941-0424, 0941-0430), STERILIZE(0941-0424, 0941-0430)

PRINCIPAL DISPLAY PANEL

NDC 0941-0411-11 Representative Container LabelNDC 0941-0411-11 (07-25-00-0740) Container Label

 L5B9710 6000 mL
NDC 0941-0411-11(APPROX 225 mL EXCESS)

BaxterLogo

Dianeal PD-2
Peritoneal Dialysis Solution
with1.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS
USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM
LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg
MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM
- 0.5 CHLORIDE - 96 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

CAUTIONS SQUEEZE AND INSPECT INNER
BAG WHICH MAINTAINS PRODUCT STERILITY
DISCARD IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

PD-2 1.5% Dextrose

Bar Code
(01)00309410411117

NDC 0941-0411-11 Representative Container LabelNDC 0941-0413-07 (07-25-00-0677) Container Label

L5B5194 5000 mL
NDC 0941-0413-07 (APPROX 150 mL EXCESS)

BaxterLogo

Dianeal PD-2
Peritoneal Dialysis Solution
with 2.5% Dextrose

EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
CHLORIDE - 96 LACTATE - 40
OSMOLARITY - 396 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

CAUTIONS SQUEEZE AND INSPECT INNER
BAG WHICH MAINTAINS PRODUCT STERILITY
DISCARD IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

PD-2 2.5% Dextrose

Bar Code
(01) 00309410413074

NDC 0941-0411-11 Representative Container LabelNDC 0941-0415-06 (07-25-56-591) Container Label

L5B5187 2000 mL
NDC 0941-0415-06 (APPROX 80 mL EXCESS)
3000 mL NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal PD-2
Peritoneal Dialysis Solution
with 4.25% Dextrose

EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
CHLORIDE - 96 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

WARNING EXTENSIVE USE OF THIS SOLUTION
DURING ONE PERITONEAL DIALYSIS PROCEDURE CAN
RESULT IN SIGNIFICANT REMOVAL OF WATER FROM
THE PATIENT

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

PD-2 4.25% Dextrose 

NDC 0941-0411-11 Representative Container LabelNDC 0941-0409-07 (07-25-00-0676) Container Label

L5B4826 5000 mL
NDC 0941-0409-07 (APPROX 150 mL EXCESS)

BaxterLogo

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 1.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS
USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM
LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg
MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM -
0.5 CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 344 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP
AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY
TO USE AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

Low Calcium 1.5% Dextrose

Bar Code
(01)00309410409077

NDC 0941-0411-11 Representative Container LabelNDC 0941-0457-08 (07-25-00-0739) Container Label

L5B9727 2000 mL
NDC 0941-0457-08 (APPROX 80 mL EXCESS)
3000 mL NOMINAL SIZE CONTANER

BaxterLogo

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 2.5% Dextrose

EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

Low Calcium 2.5% Dextrose

Bar Code
(01)00309410457085

NDC 0941-0411-11 Representative Container LabelNDC 0941-0459-08 Container Label

L5B9747 2000 mL
NDC 0941-0459-08 (APPROX 80 mL EXCESS)
3000 mL NOMINAL SIZE CONTANER

BaxterLogo

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 4.25% Dextrose

EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-642

Low Calcium 4.25% Dextrose

NDC 0941-0411-11 Representative Container LabelNDC 0941-0426-52 Container Label

07-25-47-851

5B9866 2000 mL

NDC 0941-0426-52 (APPROX 80 mL EXCESS)

BaxterLogo

Dianeal PD-2
Peritoneal Dialysis Solution
with 1.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM
LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg
MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
CHLORIDE - 96 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION

FOR INTRAPERITONEAL ADMINISTRATION ONLY

USE AS DIRECTED BY PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE

AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703
4439188 4573980

PD-2 1.5% Dextrose

NDC 0941-0411-11 Representative Container LabelNDC 0941-0427-52 Container Label

07-25-47-854
5B9876 2000 mL

NDC 0941-0427-52 (APPROX 80 mL EXCESS)

BaxterLogo
Dianeal PD-2
Peritoneal Dialysis Solution
with 2.5% Dextrose

EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM
LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg
MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
CHLORIDE - 96 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION

DOSAGE AS DIRECTED BY PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE

AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CCONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703
4439188 4573980

PD-2 2.5% Dextrose

NDC 0941-0411-11 Representative Container LabelNDC 0941-0429-52 Container Label

07-25-47-876

5B9896 2000 mL
NDC 0941-0429-52 (APPROX 80 mL EXCESS)

Baxter Logo
Dianeal PD-2
Peritoneal Dialysis Solution
with 4.25% Dextrose

EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
CHLORIDE - 96 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION

WARNING EXTENSIVE USE OF THIS SOLUTION DURING
ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN
SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT

FOR INTRAPERITONEAL ADMINISTRATION ONLY

DOSAGE AS DIRECTED BY A PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION
Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (25°C/77°F) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703
4439188 4573980

PD-2 4.25% Dextrose

NDC 0941-0411-11 Representative Container LabelNDC 0941-0424-52 Container Label

07-25-47-842

5B9766 2000 mL
NDC 0941-0424-52 (APPROX 80 mL EXCESS)

BaxterLogo

Dianeal
Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution
with 1.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSET FOR FULL INFORMATION

FOR INTRAPERITONEAL ADMINISTRATION ONLY

DOSAGE AS DIRECTED BY PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE

AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703
4439188 4573980

Low Calcium 1.5% Dextrose

NDC 0941-0411-11 Representative Container LabelNDC 0941-0430-52 (07-25-00-0683) Container Label

5B9776 2000 mL
NDC 0941-0430-52 (APPROX 80 mL EXCESS)

BaxterLogo

Dianeal
Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution
with 2.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSET FOR FULL INFORMATION

FOR INTRAPERITONEAL ADMINISTRATION ONLY

DOSAGE AS DIRECTED BY PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE

AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703
4439188 4573980

Low Calcium 2.5% Dextrose

NDC 0941-0411-11 Representative Container LabelNDC 0941-0433-52 Container Label

07-25-47-848

5B9796 2000 mL
NDC 0941-0433-52 (APPROX 80 mL EXCESS)

BaxterLogo

Dianeal
Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution
with 4.25% Dextrose

EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSET FOR FULL INFORMATION

WARNING EXTENSIVE USE OF THIS SOLUTION DURING
ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN
SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT

FOR INTRAPERITONEAL ADMINISTRATION ONLY

DOSAGE AS DIRECTED BY PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE

AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703
4439188 4573980

Low Calcium 2.5% Dextrose

NDC 0941-0411-11 Representative Container LabelNDC 0941-0484-01 Container Label

EZPB5245R
NDC 0941-0484-01

5000 mL
(APPROX 135 mL EXCESS)

BAXTER LOGO

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 1.5% Dextrose

Low Calcium 1.5% Dextrose

EACH 100 mL CONTAINS
448 mg SODIUM LACTATE
pH 5.0 to 6.5

1.5 g DEXTROSE HYDROUS
18.4 mg CALCIUM CHLORIDE

538 mg SODIUM CHLORIDE
5.08 mg MAGNESIUM CHLORIDE

mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40
OSMOLARITY – 344 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

  •   CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH
    MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE

AVOID EXCESSIVE HEAT SEE INSERT

PL 146 PLASTIC

BAXTER DIANEAL AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN IRELAND

CB-35-03-813

NDC 0941-0411-11 Representative Container Label0941-0487-01 Container Label

EZPB5255R
NDC 0941-0487-01

5000 mL
(APPROX 135 mL EXCESS)

BAXTER LOGO

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 2.5% Dextrose

Low Calcium 2.5% Dextrose

EACH 100 mL CONTAINS
448 mg SODIUM LACTATE
pH 5.0 to 6.5

2.5 g DEXTROSE HYDROUS
18.4 mg CALCIUM CHLORIDE

538 mg SODIUM CHLORIDE
5.08 mg MAGNESIUM CHLORIDE

mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40
OSMOLARITY – 395 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

  •   CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25ºC/77ºF) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT

PL 146 PLASTIC

BAXTER DIANEAL AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN IRELAND

CB-35-03-814

NDC 0941-0411-11 Representative Container LabelNDC 0941-0490-01 Container Label

EZPB5265R
NDC 0941-0490-01

5000 mL
(APPROX 135 mL EXCESS)

BAXTER LOGO

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 4.25% Dextrose

Low Calcium 4.25% Dextrose

EACH 100 mL CONTAINS
448 mg SODIUM LACTATE
pH 5.0 to 6.5

4.25 g DEXTROSE HYDROUS
18.4 mg CALCIUM CHLORIDE

538 mg SODIUM CHLORIDE
5.08 mg MAGNESIUM CHLORIDE

mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40
OSMOLARITY – 483 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

  •   CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25ºC/77ºF) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT

PL 146 PLASTIC

BAXTER DIANEAL AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN IRELAND

CB-35-03-815