NDC Code(s) : 0173-0442-00
Packager : GlaxoSmithKline LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ZOFRANondansetron hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0442
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)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0173-0442-0020 mL in 1 VIAL Type 0: Not a Combination Product04/02/1991
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020007 02/04/1991 02/28/2018

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0173-0442-00

Zofran®

(ondansetron hydrochloride)

Injection

2 mg/mL*

40 mg in 20 mL

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

Rx only

Sterile

20-mL Multidose Vial

Made in Singapore

©2014, GSK group of companies.

  •  10000000124651 Rev. 3/14
Zofran Injection 20 mL vial carton