Darunavir 600 and 800 mg
- Product NDC
- 63629-5686
- 11-digit product format
- 636295686
- Labeler code
- 63629
- Product ID
- 63629-5686_290dd3c3-c6b7-415f-99b3-680080281b30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- darunavir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA206288
- Marketing category
- ANDA
- Marketing start
- 2023-11-29
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Darunavir 600 and 800 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DARUNAVIR DIHYDRATE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KPC4NRB25L |
| Rxcui | 1359269 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-5686-1 | Darunavir 600 and 800 mg | 15 in 1 BOTTLE | TABLET | 15 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-5686-1 | 63629568601 | 15 TABLET in 1 BOTTLE (63629-5686-1) | 15 tablet | 2025-06-05 | No | No | Current |