Metformin Hydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 500 mg Tablet Bottle Label

Metformin Hydrochloride
Extended-Release Tablets, USP

500 mg

PHARMACIST: Dispense the Patient
Information provided separately to each patient.

Rx Only

image
(click image for full-size original)
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-059(NDC:51224-007)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 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 19mm
Flavor Imprint Code OE;584
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-059-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:72789-059-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:72789-059-93 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
4 NDC:72789-059-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078321 04/17/2008
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-059)

Revised: 07/2021 PD-Rx Pharmaceuticals, Inc.

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