Darunavir
- Product NDC
- 70771-1746
- 11-digit product format
- 707711746
- Labeler code
- 70771
- Product ID
- 70771-1746_1b288e91-dedb-465d-8c45-eb464dc72e89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darunavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA214085
- Marketing category
- ANDA
- Marketing start
- 2024-05-01
- 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
- 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 | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YO603Y8113 |
| Rxcui | 670026, 1359269 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1746-3 | Darunavir | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 70771-1746-5 | Darunavir | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
| 70771-1746-9 | Darunavir | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1746 | DARUNAVIR TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 1 | Current NDC, 3 package rows | 20240501_6a029063-b14c-4eee-9958-0d9eecb27726.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1746-3 | 70771174603 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1746-3) | 2024-05-01 | No | No | Current |
| 70771-1746-5 | 70771174605 | 500 TABLET, FILM COATED in 1 BOTTLE (70771-1746-5) | 2024-05-01 | No | No | Current |
| 70771-1746-9 | 70771174609 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1746-9) | 2024-05-01 | No | No | Current |