Entecavir

Product NDC

49884-548

11-digit product format

498840548

Labeler code

49884

Product ID

49884-548_8f7f3ad3-cf3e-45fc-b103-fdd5ed1c436f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Entecavir

Dosage form

TABLET, COATED

Route

ORAL

Labeler

Par Pharmaceutical, Inc.

Application

ANDA206294

Marketing category

ANDA

Marketing start

2017-03-29

Marketing end

0000-00-00

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

2020-12-31

Current FDA listing

Historical FDA.report record