Metformin Hydrochloride: Package Insert and Label Information (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 750 mg Tablet Bottle Label

750
(click image for full-size original)

METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-551(NDC:51224-107)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 750 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE K25-31
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape OVAL Size 21mm
Flavor Imprint Code OE;585
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-551-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-551-11)
1 NDC:50268-551-11 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX (50268-551-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078321 05/02/2022
Labeler — AvPAK (832926666)

Revised: 05/2022 AvPAK

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