Darunavir
- Product NDC
- 71335-2611
- 11-digit product format
- 713352611
- Labeler code
- 71335
- Product ID
- 71335-2611_585d2da0-738a-48d3-8995-bdb8959a0193
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darunavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA215389
- Marketing category
- ANDA
- Marketing start
- 2023-11-28
- Substance
- DARUNAVIR
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Darunavir
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DARUNAVIR | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YO603Y8113 |
| Rxcui | 1359269 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2611-1 | Darunavir | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 100 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2611-1 | 71335261101 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-2611-1) | 2026-03-11 | No | No | Historical |