Glyburide and Metformin Hydrochloride

Product NDC

68788-9716

11-digit product format

687889716

Labeler code

68788

Product ID

68788-9716_a2d6e676-1895-42e6-9e4b-f298cf6d1d73

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Glyburide and Metformin Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Preferred Pharmaceuticals, Inc.

Application

ANDA077870

Marketing category

ANDA

Marketing start

2013-01-10

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