ENTECAVIR

Product NDC

52343-148

11-digit product format

523430148

Labeler code

52343

Product ID

52343-148_f0a6ceb5-9a35-4142-bfe3-cbbc06994811

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

ENTECAVIR

Dosage form

TABLET

Route

ORAL

Labeler

ACETRIS HEALTH, LLC

Application

ANDA206217

Marketing category

ANDA

Marketing start

2017-02-06

Marketing end

2020-01-01

Substance

ENTECAVIR

Active strength

1 mg/1

Pharmacologic classes

Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record