NDC Code(s) : 0641-6166-01, 0641-6166-10, 0641-6167-01, 0641-6167-10
Packager : Hikma Pharmaceuticals USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amikacin SulfateAmikacin Sulfate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6166
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIKACIN SULFATE(UNII: N6M33094FD)
(AMIKACIN - UNII:84319SGC3C) 		AMIKACIN250 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
SULFURIC ACID(UNII: O40UQP6WCF)
WATER(UNII: 059QF0KO0R)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-6166-1010 in 1 CARTON 08/01/2015
1NDC:0641-6166-014 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA063315 08/01/2015
Amikacin SulfateAmikacin Sulfate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6167
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIKACIN SULFATE(UNII: N6M33094FD)
(AMIKACIN - UNII:84319SGC3C) 		AMIKACIN250 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
SULFURIC ACID(UNII: O40UQP6WCF)
WATER(UNII: 059QF0KO0R)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-6167-1010 in 1 CARTON 08/01/2015
1NDC:0641-6167-012 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA063315 08/01/2015

LABELER - Hikma Pharmaceuticals USA Inc.(946499746)

Establishment
Name Address ID/FEI Business Operations
Hikma Pharmaceuticals USA Inc. 946499746 analysis(0641-6166, 0641-6167), label(0641-6166, 0641-6167), manufacture(0641-6166, 0641-6167), pack(0641-6166, 0641-6167)

PRINCIPAL DISPLAY PANEL

NDC 0641-6167-01       Rx only
Amikacin
Sulfate
Injection, USP
equivalent to amikacin
500 mg per 2 mL
(250 mg/mL)
For IM or IV use
2 mL Single Dose Vial

vial 

NDC 0641-6167-10       Rx only
Amikacin
Sulfate Injection, USP
equivalent to amikacin
500 mg per 2 mL
(250 mg/mL)
For Intramuscular or
Intravenous use
10 x 2 mL Single Dose Vials

vial 

PRINCIPAL DISPLAY PANEL

NDC 0641-6166-01       Rx only
Amikacin
Sulfate Injection, USP
equivalent to amikacin
1 g per 4 mL
(250 mg/mL)
For IM or IV use
4 mL Vial

vial 

NDC 0641-6166-10       Rx only
Amikacin
Sulfate Injection, USP
equivalent to amikacin
1 g per 4 mL
(250 mg/mL)
For Intramuscular or Intravenous use
10 x 4 mL Vials

vial