PREZCOBIX
- Product NDC
- 59676-578
- 11-digit product format
- 596760578
- Labeler code
- 59676
- Product ID
- 59676-578_9d92f536-2a35-4d1d-baca-8d87e8b8dcaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DARUNAVIR ETHANOLATE and COBICISTAT
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Janssen Products, LP
- Application
- NDA205395
- Marketing category
- NDA
- Marketing start
- 2025-03-21
- Substance
- COBICISTAT; DARUNAVIR ETHANOLATE
- Active strength
- 150; 675 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| LW2E03M5PG | COBICISTAT | 1004316-88-4 | COBICISTAT |
| 33O78XF0BW | DARUNAVIR ETHANOLATE | 635728-49-3 | DARUNAVIR ETHANOLATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59676-578-30 | 59676057830 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-578-30) | 2025-03-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| PREZCOBIX | Janssen Products, LP | Gilead Alberta ULC | Cilag AG | Porton Pharma Solutions Ltd | Janssen Ortho LLC | Janssen Pharmaceutical Sciences Unlimited Company | Thermo Fisher Scientific Cork Limited | Yuhan Chemical, Inc. | Patheon Inc. | 2026-02-01 | HUMAN PRESCRIPTION DRUG LABEL | 28 |