NDC Code(s) : 68071-2636-9, 68071-2636-3, 68071-2636-6
Packager : NuCare Pharmaceuticals,Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2636(NDC:75834-500)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white (White to off-white) Score no score
Shape CAPSULE (biconvex, beveled edge) Size 18 mm
Flavor Imprint Code IL001
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68071-2636-990 in 1 BOTTLE Type 0: Not a Combination Product02/04/2022
2NDC:68071-2636-330 in 1 BOTTLE Type 0: Not a Combination Product02/04/2022
3NDC:68071-2636-660 in 1 BOTTLE Type 0: Not a Combination Product02/04/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201991 11/01/2013

LABELER - NuCare Pharmaceuticals,Inc.(010632300)

Establishment
Name Address ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 repack(68071-2636)

PRINCIPAL DISPLAY PANEL

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