darunavir
- Product NDC
- 76282-738
- 11-digit product format
- 762820738
- Labeler code
- 76282
- Product ID
- 76282-738_d4f6fed4-1a95-4d9a-8395-13818dedccd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- darunavir 800 mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- EXELAN PHARMACEUTICALS INC.
- Application
- ANDA206288
- Marketing category
- ANDA
- Marketing start
- 2024-01-19
- Substance
- DARUNAVIR HYDRATE
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- darunavir
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DARUNAVIR HYDRATE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KPC4NRB25L |
| Rxcui | 670026, 1359269 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76282-738-30 | darunavir | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-738 | DARUNAVIR (DARUNAVIR 600 MG) TABLET DARUNAVIR (DARUNAVIR 800 MG) TABLET [EXELAN PHARMACEUTICALS INC.] | 1 | Current NDC, 1 package rows | 20240123_ed977166-7ac0-4a8c-a10c-4b19a69403c0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76282-738-30 | 76282073830 | 30 TABLET in 1 BOTTLE (76282-738-30) | 30 tablet | 2024-01-19 | No | No | Current |