Darunavir
- Product NDC
- 60687-819
- 11-digit product format
- 606870819
- Labeler code
- 60687
- Product ID
- 60687-819_1a392399-f30c-b533-e063-6294a90a1e67
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darunavir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA206288
- Marketing category
- ANDA
- Marketing start
- 2024-06-09
- Substance
- DARUNAVIR DIHYDRATE
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60687-819-21 | 60687081921 | 30 BLISTER PACK in 1 CARTON (60687-819-21) / 1 TABLET in 1 BLISTER PACK (60687-819-11) | 30 blister pack | 2024-06-09 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Darunavir | American Health Packaging | 2024-06-09 | HUMAN PRESCRIPTION DRUG LABEL | 2 |