Nevirapine

Product NDC

0378-6950

11-digit product format

003786950

Labeler code

0378

Product ID

0378-6950_8c7d776f-cbd2-4de8-85b9-efe2cf74a71c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

nevirapine

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA206271

Marketing category

ANDA

Marketing start

2015-11-09

Marketing end

2019-10-31

Substance

NEVIRAPINE

Active strength

100 mg/1

Pharmacologic classes

Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record