NDC Code(s) : 0615-8185-39, 0615-8185-10, 0615-8185-05
Packager : NCS HealthCare of KY, LLC dba Vangard Labs

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ondansetron hydrochlorideondansetron hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-8185(NDC:55111-153)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON HYDROCHLORIDE(UNII: NMH84OZK2B)
(ONDANSETRON - UNII:4AF302ESOS) 		ONDANSETRON4 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color white Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code R;153
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0615-8185-3930 in 1 BLISTER PACK Type 0: Not a Combination Product11/07/2018
2NDC:0615-8185-1010 in 1 BLISTER PACK Type 0: Not a Combination Product11/07/2018
3NDC:0615-8185-0515 in 1 BLISTER PACK Type 0: Not a Combination Product24/03/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076183 12/26/2006

LABELER - NCS HealthCare of KY, LLC dba Vangard Labs(050052943)

Establishment
Name Address ID/FEI Business Operations
NCS HealthCare of KY, LLC dba Vangard Labs 050052943 repack(0615-8185)

PRINCIPAL DISPLAY PANEL

Principal Display Panel- Ondansetron 4mg tabs bingo label