METFORMIN HYDROCHLORIDE

Product NDC

0781-5503

11-digit product format

007815503

Labeler code

0781

Product ID

0781-5503_23461ab7-f7ed-4ae4-9392-652efccd95d5

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

metformin hydrochloride

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

SANDOZ INC.

Application

ANDA201991

Marketing category

ANDA

Marketing start

2016-11-25

Marketing end

2019-12-31

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