NDC Code(s) : 0409-7879-13, 0409-7881-13, 0409-7883-13, 0409-7884-23, 0409-7886-23, 0409-7889-23
Packager : Hospira, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Gentamicin Sulfate in Sodium ChlorideGENTAMICIN SULFATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7879
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTAMICIN SULFATE(UNII: 8X7386QRLV)
(GENTAMICIN - UNII:T6Z9V48IKG) 		GENTAMICIN1.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
SULFURIC ACID(UNII: O40UQP6WCF)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-7879-1324 in 1 CASE
11 in 1 POUCH
150 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
ANDA ANDA062414 08/15/1983
Gentamicin Sulfate in Sodium ChlorideGENTAMICIN SULFATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7881
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTAMICIN SULFATE(UNII: 8X7386QRLV)
(GENTAMICIN - UNII:T6Z9V48IKG) 		GENTAMICIN1.4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
SULFURIC ACID(UNII: O40UQP6WCF)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-7881-1324 in 1 CASE
11 in 1 POUCH
150 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
ANDA ANDA062414 08/15/1983
Gentamicin Sulfate in Sodium ChlorideGENTAMICIN SULFATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7883
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTAMICIN SULFATE(UNII: 8X7386QRLV)
(GENTAMICIN - UNII:T6Z9V48IKG) 		GENTAMICIN1.6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
SULFURIC ACID(UNII: O40UQP6WCF)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-7883-1324 in 1 CASE
11 in 1 POUCH
150 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
ANDA ANDA062414 08/15/1983
Gentamicin Sulfate in Sodium ChlorideGENTAMICIN SULFATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7884
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTAMICIN SULFATE(UNII: 8X7386QRLV)
(GENTAMICIN - UNII:T6Z9V48IKG) 		GENTAMICIN0.8 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
SULFURIC ACID(UNII: O40UQP6WCF)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-7884-2324 in 1 CASE
11 in 1 POUCH
1100 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
ANDA ANDA062414 08/15/1983
Gentamicin Sulfate in Sodium ChlorideGENTAMICIN SULFATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7886
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTAMICIN SULFATE(UNII: 8X7386QRLV)
(GENTAMICIN - UNII:T6Z9V48IKG) 		GENTAMICIN0.9 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
SULFURIC ACID(UNII: O40UQP6WCF)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-7886-2324 in 1 CASE
11 in 1 POUCH
1100 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
ANDA ANDA062414 08/15/1983
Gentamicin Sulfate in Sodium ChlorideGENTAMICIN SULFATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7889
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTAMICIN SULFATE(UNII: 8X7386QRLV)
(GENTAMICIN - UNII:T6Z9V48IKG) 		GENTAMICIN1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
SULFURIC ACID(UNII: O40UQP6WCF)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-7889-2324 in 1 CASE
11 in 1 POUCH
1100 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
ANDA ANDA062414 08/15/1983

PRINCIPAL DISPLAY PANEL

iv bag ndc 0409-7879-13

PRINCIPAL DISPLAY PANEL

iv bag ndc 0409-7881-13

PRINCIPAL DISPLAY PANEL

iv bag ndc 0409-7883-13

PRINCIPAL DISPLAY PANEL

iv bag ndc 0409-7884-23

PRINCIPAL DISPLAY PANEL

iv bag ndc 0409-7886-23

PRINCIPAL DISPLAY PANEL

iv bag ndc 0409-7889-23