Darunavir
- Product NDC
- 68071-3910
- 11-digit product format
- 680713910
- Labeler code
- 68071
- Product ID
- 68071-3910_42de77fa-91bb-20bb-e063-6394a90ad54d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darunavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA210677
- Marketing category
- ANDA
- Marketing start
- 2023-11-28
- Substance
- DARUNAVIR PROPYLENE GLYCOLATE
- Active strength
- 800 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 |
|---|
| 68071-3910-3 | 68071391003 | 3 TABLET, FILM COATED in 1 BOTTLE (68071-3910-3) | 2025-11-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Darunavir | NuCare Pharmaceuticals, Inc. | 2025-11-05 | HUMAN PRESCRIPTION DRUG LABEL | 2 |