NDC Code(s) : 0641-6078-01, 0641-6078-25, 0641-6079-01
Packager : Hikma Pharmaceuticals USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OndansetronOndansetron INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6078
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON HYDROCHLORIDE(UNII: NMH84OZK2B)
(ONDANSETRON - UNII:4AF302ESOS) 		ONDANSETRON2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)0.5 mg in 1 mL
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)0.25 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-6078-2525 in 1 CARTON 26/12/2006
1NDC:0641-6078-012 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 ANDA077541 12/26/2006
OndansetronOndansetron INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6079
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON HYDROCHLORIDE(UNII: NMH84OZK2B)
(ONDANSETRON - UNII:4AF302ESOS) 		ONDANSETRON2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.3 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)0.5 mg in 1 mL
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)0.25 mg in 1 mL
WATER(UNII: 059QF0KO0R)
METHYLPARABEN(UNII: A2I8C7HI9T)1.2 mg in 1 mL
PROPYLPARABEN(UNII: Z8IX2SC1OH)0.15 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-6079-0120 mL in 1 CARTON Type 0: Not a Combination Product26/12/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077365 12/26/2006

LABELER - Hikma Pharmaceuticals USA Inc.(946499746)

Establishment
Name Address ID/FEI Business Operations
Hikma Pharmaceuticals USA Inc. 946499746 analysis(0641-6078, 0641-6079), label(0641-6078, 0641-6079), manufacture(0641-6078, 0641-6079)

PRINCIPAL DISPLAY PANEL

NDC 0641-6078-01    Rx only
Ondansetron Injection, USP
4 mg per 2 mL
(2 mg/mL)
For IV or IM Injection
Protect from light
2 mL Single Dose Vial

462-395-03

NDC 0641-6078-25     Rx only
Ondansetron Injection, USP
4 mg per 2 mL (2 mg/mL)*
For Intravenous or Intramuscular injection
25 x 2 mL Single Dose Vials

462-395-03

PRINCIPAL DISPLAY PANEL

NDC 0641-6079-01    Rx only
Ondansetron Injection, USP
40 mg per 20 mL (2 mg/mL)*
For Intravenous or Intramuscular injection
20 mL Multiple Dose Vial

462-388-04

NDC 0641-6079-01    Rx only
Ondansetron Injection, USP
40 mg per 20 mL (2 mg/mL)*
For Intravenous or Intramuscular injection
Sterile
20 mL Multiple Dose Vial

462-388-04

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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