Glyburide and Metformin Hydrochloride

Product NDC

0115-1649

11-digit product format

001151649

Labeler code

0115

Product ID

0115-1649_5531ac0a-ef76-41f1-9845-f3d1f6bd82dd

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Glyburide and Metformin Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Impax Generics

Application

ANDA076716

Marketing category

ANDA

Marketing start

2016-08-03

Marketing end

0000-00-00

Substance

GLYBURIDE; METFORMIN HYDROCHLORIDE

Active strength

3 mg/1; mg/1

Pharmacologic classes

Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record