Metformin Hydrochloride

Basic Information

Product Name

FDA Product Code

53808-0717

Regulatory Information

NDC Product Code

53808-0717

Application Number

ANDA078170

Marketing Category

C73584

Effective Date

August 9, 2010

Territorial Authority

USA

FDA Title

Metformin Hydrochloride Tablets USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

METFORMIN HYDROCHLORIDE

Quantity: 850 mg in 1 1

Code: 786Z46389E

Class Code: ACTIB

POVIDONE

Code: FZ989GH94E

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE

Code: 3NXW29V3WO

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

Active Moieties

METFORMIN

Code: 9100L32L2N

Basic Information

Regulatory Information

Company Information

Active Ingredients

POLYETHYLENE GLYCOL 6000

POVIDONE

CELLULOSE, MICROCRYSTALLINE

MAGNESIUM STEARATE

HYPROMELLOSE

POLYETHYLENE GLYCOL 400

Active Moieties

METFORMIN