NDC Code(s) : 35356-445-30
Packager : Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-445(NDC:0093-7236)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON HYDROCHLORIDE(UNII: NMH84OZK2B)
(ONDANSETRON - UNII:4AF302ESOS) 		ONDANSETRON8 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code 93;7236
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-445-3030 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076252 11/03/2011

PRINCIPAL DISPLAY PANEL

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