Darunavir
- Product NDC
- 59651-085
- 11-digit product format
- 596510085
- Labeler code
- 59651
- Product ID
- 59651-085_2b5403e0-28fe-44ef-9b80-f754181ba220
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darunavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA210677
- Marketing category
- ANDA
- Marketing start
- 2023-11-28
- Substance
- DARUNAVIR PROPYLENE GLYCOLATE
- Active strength
- 600 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 PROPYLENE GLYCOLATE | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M6D7F3VC7 |
| Rxcui | 670026, 1359269 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-085-60 | Darunavir | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-085 | DARUNAVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 1 package rows | 20240628_88910ad0-6dc3-4a47-8a6b-5c6ee79f2a93.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-085-60 | 59651008560 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-085-60) | 2023-11-28 | No | No | Historical |