Metformin Hydrochloride

Basic Information

Product Name

FDA Product Code

50090-0771

Regulatory Information

NDC Product Code

50090-0771

Application Number

ANDA075967

Marketing Category

C73584

Effective Date

August 2, 2018

Territorial Authority

USA

FDA Title

Metformin Hydrochloride Tablets, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

METFORMIN HYDROCHLORIDE

Quantity: 500 mg in 1 1

Code: 786Z46389E

Class Code: ACTIB

Active Moieties

METFORMIN

Code: 9100L32L2N

Basic Information

Regulatory Information

Company Information

Active Ingredients

POVIDONE, UNSPECIFIED

POLYETHYLENE GLYCOL, UNSPECIFIED

MAGNESIUM STEARATE

LACTOSE MONOHYDRATE

HYPROMELLOSE, UNSPECIFIED

TITANIUM DIOXIDE

TRIACETIN

Active Moieties

METFORMIN