PREZCOBIX PED

Product NDC

59676-577

11-digit product format

596760577

Labeler code

59676

Product ID

59676-577_9d92f536-2a35-4d1d-baca-8d87e8b8dcaf

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

DARUNAVIR ETHANOLATE and COBICISTAT

Dosage form

TABLET, FOR SUSPENSION

Route

ORAL

Labeler

Janssen Products, LP

Application

NDA205395

Marketing category

NDA

Marketing start

2026-02-27

Substance

COBICISTAT; DARUNAVIR ETHANOLATE

Active strength

90; 600 mg/1; mg/1

Pharmacologic classes

Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC]

NDC exclude flag

No

Listing certified through

2027-12-31

Current FDA listing

Yes