NDC Code(s) : 68071-3472-9
Packager : NuCare Pharmaceuticals,Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GABAPENTINGabapentin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-3472(NDC:31722-167)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN(UNII: 6CW7F3G59X)
(GABAPENTIN - UNII:6CW7F3G59X) 		GABAPENTIN800 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
CROSPOVIDONE(UNII: 2S7830E561)
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 19 mm
Flavor Imprint Code T;3
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68071-3472-990 in 1 BOTTLE Type 0: Not a Combination Product26/07/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214957 10/01/2021

LABELER - NuCare Pharmaceuticals,Inc.(010632300)

Establishment
Name Address ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 repack(68071-3472)

PRINCIPAL DISPLAY PANEL

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