NDC Code(s) : 0069-1340-05, 0069-1340-16
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ondansetron HydrochlorideOndansetron Hydrochloride INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-1340
Route of Administration INTRAVENOUS, INTRAMUSCULAR 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)
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:0069-1340-1625 in 1 CARTON
1NDC:0069-1340-052 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078244 05/10/2011

PRINCIPAL DISPLAY PANEL

NDC 0069-1340-16
Contains 25 of NDC 0069-1340-05

25 x 2 mL Single Use Vials
Rx only

ondansetron
injection USP
4 mg/2 mL (2 mg/mL)

Sterile
For I.V. or I.M. Injection

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 2 mL Single Use Vial Carton