Glimepiride

Product NDC

0378-4013

11-digit product format

003784013

Labeler code

0378

Product ID

0378-4013_ce446aec-73b0-46a4-90a2-d4dea357ebfa

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

glimepiride

Dosage form

TABLET

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA077624

Marketing category

ANDA

Marketing start

2006-03-01

Marketing end

2020-05-31

Substance

GLIMEPIRIDE

Active strength

4 mg/1

Pharmacologic classes

Sulfonylurea [EPC],Sulfonylurea Compounds [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record