Glyburide and Metformin Hydrochloride

Product NDC

68071-4453

11-digit product format

680714453

Labeler code

68071

Product ID

68071-4453_6d5ed0f9-fb31-7855-e053-2991aa0a18a8

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Glyburide and Metformin Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

NuCare Pharmaceuticals,Inc.

Application

ANDA077870

Marketing category

ANDA

Marketing start

2007-11-14

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

2020-12-31

Current FDA listing

Historical FDA.report record