METFORMIN HYDROCHLORIDE

Product NDC

68382-027

11-digit product format

683820027

Labeler code

68382

Product ID

68382-027_4ca45053-c36e-40b6-a92a-b773bbbe830d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

METFORMIN HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Zydus Pharmaceuticals (USA) Inc.

Application

ANDA077060

Marketing category

ANDA

Marketing start

2005-09-28

Marketing end

0000-00-00

Substance

METFORMIN HYDROCHLORIDE

Active strength

500 mg/1

Pharmacologic classes

Biguanide [EPC],Biguanides [CS]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record