PREZISTA

Product NDC

50090-1491

11-digit product format

500901491

Labeler code

50090

Product ID

50090-1491_366ef3e4-d6e2-470e-8363-1ab2637cd83f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

darunavir

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

A-S Medication Solutions

Application

NDA021976

Marketing category

NDA

Marketing start

2008-03-08

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

2020-12-31

Current FDA listing

Historical FDA.report record