Metformin Hydrochloride

Basic Information

Product Name

FDA Product Code

43063-544

Regulatory Information

NDC Product Code

43063-544

Application Number

ANDA077880

Marketing Category

C73584

Effective Date

September 26, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS . METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

ACACIA

Code: 5C5403N26O

Class Code: IACT

MALTODEXTRIN

Code: 7CVR7L4A2D

Class Code: IACT

METFORMIN HYDROCHLORIDE

Quantity: 1000 mg in 1 1

Code: 786Z46389E

Class Code: ACTIB

Active Moieties

METFORMIN

Code: 9100L32L2N

Basic Information

Regulatory Information

Company Information

Active Ingredients

PROPYLENE GLYCOL

ACACIA

MALTODEXTRIN

Active Moieties

METFORMIN