NDC Code(s) : 68071-4115-2, 68071-4115-4, 68071-4115-3
Packager : NuCare Pharmaceuticals,Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OndansetronOndansetron TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-4115(NDC:68462-157)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON(UNII: 4AF302ESOS)
(ONDANSETRON - UNII:4AF302ESOS) 		ONDANSETRON4 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
Product Characteristics
Color white Score no score
Shape ROUND Size 7 mm
Flavor STRAWBERRY Imprint Code G;4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68071-4115-22 in 1 BOTTLE Type 0: Not a Combination Product16/10/2017
2NDC:68071-4115-44 in 1 BOTTLE Type 0: Not a Combination Product16/10/2017
3NDC:68071-4115-33 in 1 BOTTLE Type 0: Not a Combination Product27/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078152 06/27/2007

LABELER - NuCare Pharmaceuticals,Inc.(010632300)

Establishment
Name Address ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 repack(68071-4115)

PRINCIPAL DISPLAY PANEL

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