Glyburide and Metformin Hydrochloride

Product NDC

43063-397

11-digit product format

430630397

Labeler code

43063

Product ID

43063-397_7ced46ec-b662-f70d-e053-2a91aa0ab845

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Glyburide and Metformin Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA076716

Marketing category

ANDA

Marketing start

2005-06-28

Marketing end

0000-00-00

Substance

GLYBURIDE; METFORMIN HYDROCHLORIDE

Active strength

5 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