Metformin Hydrochloride

Basic Information

Product Name

FDA Product Code

70010-064

Regulatory Information

NDC Product Code

70010-064

Application Number

ANDA090564

Marketing Category

C73584

Effective Date

August 9, 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

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

BLACKBERRY

Code: 8A6OMU3I8L

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

METFORMIN HYDROCHLORIDE

Quantity: 850 mg in 1 1

Code: 786Z46389E

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

POVIDONE K90

Code: RDH86HJV5Z

Class Code: IACT

Active Moieties

METFORMIN

Code: 9100L32L2N

Basic Information

Regulatory Information

Company Information

Active Ingredients

HYPROMELLOSE 2910 (6 MPA.S)

BLACKBERRY

POLYETHYLENE GLYCOL 400

POVIDONE K30

MAGNESIUM STEARATE

TITANIUM DIOXIDE

STARCH, CORN

POVIDONE K90

Active Moieties

METFORMIN