Darunavir
- Product NDC
- 70771-1745
- 11-digit product format
- 707711745
- Labeler code
- 70771
- Product ID
- 70771-1745_1b288e91-dedb-465d-8c45-eb464dc72e89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darunavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA214085
- Marketing category
- ANDA
- Marketing start
- 2024-05-01
- Substance
- DARUNAVIR
- Active strength
- 600 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| YO603Y8113 | DARUNAVIR | 206361-99-1 | DARUNAVIR |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1745-5 | 70771174505 | 500 TABLET, FILM COATED in 1 BOTTLE (70771-1745-5) | 2024-05-01 | No | No | Historical |
| 70771-1745-6 | 70771174506 | 60 TABLET, FILM COATED in 1 BOTTLE (70771-1745-6) | 2024-05-01 | No | No | Historical |
| 70771-1745-8 | 70771174508 | 180 TABLET, FILM COATED in 1 BOTTLE (70771-1745-8) | 2024-05-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Darunavir Tablets | Zydus Lifesciences Limited | 2024-04-29 | HUMAN PRESCRIPTION DRUG LABEL | 1 |