Prescription Drug Information: Metformin Hydrochloride (Page 6 of 6)

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.

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Medication Sections

Medication Information by RSS

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.