Metformin Hydrochloride Extended Release

Product NDC

0904-5794

11-digit product format

009045794

Labeler code

0904

Product ID

0904-5794_211ea211-30cb-474a-9d30-c5cd0a77fc34

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

metformin hydrochloride

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Major Pharmaceuticals

Application

ANDA076706

Marketing category

ANDA

Marketing start

2009-06-10

Marketing end

2020-09-30

Substance

METFORMIN HYDROCHLORIDE

Active strength

500 mg/1

Pharmacologic classes

Biguanide [EPC],Biguanides [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record