NDC Code(s) : 0338-9545-50, 0338-9545-24, 0338-9549-50, 0338-9549-24, 0338-9553-50, 0338-9553-24
Packager : Baxter Healthcare Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

clindamycin phosphateclindamycin phosphate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9545
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE(UNII: EH6D7113I8)
(CLINDAMYCIN - UNII:3U02EL437C) 		CLINDAMYCIN PHOSPHATE300 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)2.00 mg in 50 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)450 mg in 50 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0338-9545-2424 in 1 CARTON 20/04/2017
1NDC:0338-9545-5050 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208083 04/20/2017
clindamycin phosphateclindamycin phosphate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9549
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE(UNII: EH6D7113I8)
(CLINDAMYCIN - UNII:3U02EL437C) 		CLINDAMYCIN PHOSPHATE600 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)2.00 mg in 50 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)450 mg in 50 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0338-9549-2424 in 1 CARTON 20/04/2017
1NDC:0338-9549-5050 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208083 04/20/2017
clindamycin phosphateclindamycin phosphate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9553
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE(UNII: EH6D7113I8)
(CLINDAMYCIN - UNII:3U02EL437C) 		CLINDAMYCIN PHOSPHATE900 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)2.00 mg in 50 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)450 mg in 50 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0338-9553-2424 in 1 CARTON 20/04/2017
1NDC:0338-9553-5050 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208083 04/20/2017

LABELER - Baxter Healthcare Corporation(005083209)

Establishment
Name Address ID/FEI Business Operations
Baxter Healthcare Corporation 194684502 ANALYSIS(0338-9545, 0338-9549, 0338-9553), LABEL(0338-9545, 0338-9549, 0338-9553), MANUFACTURE(0338-9545, 0338-9549, 0338-9553), PACK(0338-9545, 0338-9549, 0338-9553), STERILIZE(0338-9545, 0338-9549, 0338-9553)

PRINCIPAL DISPLAY PANEL

Clindamycin Phosphate in Sod. Chlor. container NDC 0338-9545-50 panel 1 of 2 Clindamycin Phosphate in Sod. Chlor. container NDC 0338-9545-50 panel 1 of 2Container Label

NDC 0338-9545-50
Clindamycin Phosphate
in 0.9% Sodium Chloride Injection
300 mg per 50 mL (6 mg / mL)

50 mL Single-Dose GALAXY Container
Code 2G3455

Discard unused portion
Sterile Nonpyrogenic

For Intravenous Infusion Only

Cautions: Do not add supplementary medication. Must not be used in
series connections. Check for minute leaks and solution clarity.

Each 50 mL contains: Clindamycin phosphate, USP equivalent to
300 mg clindamycin, 450 mg sodium chloride, USP, 2 mg edetate
disodium dihydrate, USP, and Water for Injection, USP. pH may have
been adjusted with sodium hydroxide and/or hydrochloric acid.

Dosage: See prescribing information.

Rx only
Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature].
Avoid temperatures above 30°C.

BAXTER Logo

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Made in USA

07-34-00-2141

Bar Code Position Only
303389545507

Clindamycin Phosphate in Sod. Chlor. container NDC 0338-9545-50 panel 1 of 2Clindamycin Phosphate in Sod. Chlor. container NDC 0338-9545-50 panel 1 of 2Carton Label

GALAXY Container

BAXTER Logo

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Made in USA

07-04-00-1232

Clindamycin Phosphate in 0.9% Sodium Chloride Injection
300 mg per 50 mL (6 mg / mL)
Contains 12 - 50 mL Single-Dose Containers
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Avoid temperatures above 30°C.

Rx only
NDC 0338-9545-24
Code 2G3455

FOR BAR CODE POSITION ONLY
(01) 20303389545242

For Intravenous Infusion Only
Sterile Nonpyrogenic

Each 50 mL contains: Clindamycin phosphate, USP equivalent to 300 mg clindamycin,
450 mg sodium chloride, USP, 2 mg edetate disodium dihydrate, USP, and Water for Injection, USP.
pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.
Dosage: See prescribing information.
Cautions: Do not add supplementary medication. Must not be used in series connections.
Check for minute leaks and solution clarity.

Clindamycin Phosphate in Sod. Chlor. container NDC 0338-9545-50 panel 1 of 2 Clindamycin Phosphate in Sod. Chlor. container NDC 0338-9545-50 panel 1 of 2Container Label

NDC 0338-9549-50
 Clindamycin Phosphate
in 0.9% Sodium Chloride Injection

600 mg per 50 mL (12 mg / mL)

50 mL Single-Dose GALAXY Container
Code 2G3456

Discard unused portion
For Intravenous Use Only

Sterile Nonpyrogenic

Cautions: Do not add supplementary medication. Must not be used in
series connections. Check for minute leaks and solution clarity.

Each 50 mL contains: Clindamycin phosphate, USP equivalent to
600 mg clindamycin, 450 mg sodium chloride, USP, 2 mg edetate
disodium dihydrate, USP, and Water for Injection, USP. pH may have
been adjusted with sodium hydroxide and/or hydrochloric acid.

Dosage: See prescribing information.

Rx only
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Avoid temperatures above 30°C.

BAXTER Logo

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Made in USA

07-34-00-2158

BAR CODE POSTION ONLY
303389549505

Clindamycin Phosphate in Sod. Chlor. container NDC 0338-9545-50 panel 1 of 2Clindamycin Phosphate in Sod. Chlor. container NDC 0338-9545-50 panel 1 of 2Carton Label

GALAXY Container

BAXTER Logo

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Made in USA

07-04-00-1233

Clindamycin Phosphate in 0.9% Sodium Chloride Injection
600 mg per 50 mL (12 mg / mL)
Contains 12 - 50 mL Single-Dose Containers
Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]. Avoid temperatures above 30°C.

Rx only
NDC 0338-9549-24
Code 2G3456

FOR BAR CODE POSITION ONLY
(01) 20303389549240

For Intravenous Infusion Only
Sterile Nonpyrogenic

Each 50 mL contains: Clindamycin phosphate, USP equivalent to 600 mg clindamycin,
450 mg sodium chloride, USP, 2 mg edetate disodium dihydrate, USP, and Water for Injection, USP.
pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.
Dosage: See prescribing information.
Cautions: Do not add supplementary medication. Must not be used in series connections.
Check for minute leaks and solution clarity.

Clindamycin Phosphate in Sod. Chlor. container NDC 0338-9545-50 panel 1 of 2 Clindamycin Phosphate in Sod. Chlor. container NDC 0338-9545-50 panel 1 of 2Container Label

NDC 0338-9553-50
Clindamycin Phosphate in 0.9% Sodium Chloride Injection

900 mg per 50 mL (18 mg / mL)

50 mL Single-Dose GALAXY Container
Code 2G3457
Discard unused portion
Sterile Nonpyrogenic
For Intravenous Infusion Only

Cautions: Do not add supplementary medication. Must not be used in
series connections. Check for minute leaks and solution clarity.

Each 50 mL contains: Clindamycin phosphate, USP equivalent to
900 mg clindamycin, 450 mg sodium chloride, USP, 2 mg edetate
disodium dihydrate, USP, and Water for Injection, USP. pH may have
been adjusted with sodium hydroxide and/or hydrochloric acid.
Dosage: See prescribing information.

Rx only
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Avoid temperatures above 30°C.

BAXTER Logo

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Made in USA

07-34-00-2159

BAR CODE POSITION ONLY
303389553502

Clindamycin Phosphate in Sod. Chlor. container NDC 0338-9545-50 panel 1 of 2Clindamycin Phosphate in Sod. Chlor. container NDC 0338-9545-50 panel 1 of 2Carton Label

GALAXY Container

BAXTER Logo

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Made in USA

07-04-00-1234

Clindamycin Phosphate in 0.9% Sodium Chloride Injection
900 mg per 50 mL (18 mg / mL)
Contains 12 - 50 mL Single-Dose Containers
Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]. Avoid temperatures above 30°C.

Rx only
NDC 0338-9553-24
Code 2G3457

FOR BAR CODE POSITION ONLY
(01) 20303389553247

For Intravenous Infusion Only
Sterile Nonpyrogenic

Each 50 mL contains: Clindamycin phosphate, USP equivalent to 900 mg clindamycin,
450 mg sodium chloride, USP, 2 mg edetate disodium dihydrate, USP, and Water for Injection, USP.
pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.
Dosage: See prescribing information.
Caution: Do not add supplementary medication. Must not be used in series connections.
Check for minute leaks and solution clarity.