Glyburide and Metformin Hydrochloride

Product NDC

55700-612

11-digit product format

557000612

Labeler code

55700

Product ID

55700-612_b4c7bebf-5c2a-4fa6-a72e-23cacfcb96d4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Glyburide and Metformin Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA077870

Marketing category

ANDA

Marketing start

2018-05-04

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