METFORMIN HYDROCHLORIDE

Product NDC

55700-618

11-digit product format

557000618

Labeler code

55700

Product ID

55700-618_2018803c-f87c-4eac-a8ea-a2fe361833cc

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

metformin hydrochloride

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA201991

Marketing category

ANDA

Marketing start

2018-05-11

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