PREZISTA

Product NDC

70518-0689

11-digit product format

705180689

Labeler code

70518

Product ID

70518-0689_6818b4b6-ba19-d852-e053-2991aa0a87c3

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

darunavir

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

NDA021976

Marketing category

NDA

Marketing start

2017-08-21

Marketing end

0000-00-00

Substance

DARUNAVIR ETHANOLATE

Active strength

600 mg/1

Pharmacologic classes

HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record