DARUNAVIR
- Product NDC
- 68180-346
- 11-digit product format
- 681800346
- Labeler code
- 68180
- Product ID
- 68180-346_f2b03ba0-704c-447a-a7ab-b4eb00243295
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DARUNAVIR
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA202073
- Marketing category
- ANDA
- Marketing start
- 2023-06-01
- Substance
- DARUNAVIR ETHANOLATE
- 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 |
|---|
| 33O78XF0BW | DARUNAVIR ETHANOLATE | 635728-49-3 | DARUNAVIR ETHANOLATE |
| YO603Y8113 | DARUNAVIR | 206361-99-1 | DARUNAVIR |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68180-346-06 | 68180034606 | 30 TABLET, FILM COATED in 1 BOTTLE (68180-346-06) | 2023-06-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| DARUNAVIR | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-10-23 | HUMAN PRESCRIPTION DRUG LABEL | 24 |
| DARUNAVIR | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2024-01-03 | HUMAN PRESCRIPTION DRUG LABEL | 23 |