Metformin Hydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — Container Label

PDP
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METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2316(NDC:42385-902)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 1000 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
POVIDONE K30
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
Product Characteristics
Color white (White to off white) Score 2 pieces
Shape OVAL (Oval-Biconvex) Size 19mm
Flavor BLACKBERRY Imprint Code L;11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-2316-6 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209882 01/15/2019
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-2316)

Revised: 01/2022 NuCare Pharmaceuticals,Inc.

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