Darunavir
- Product NDC
- 72205-184
- 11-digit product format
- 722050184
- Labeler code
- 72205
- Product ID
- 72205-184_ea6e0136-75b2-4793-9500-04e6658a0a73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darunavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA215389
- Marketing category
- ANDA
- Marketing start
- 2023-11-28
- Substance
- DARUNAVIR
- 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 | 600 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 |
|---|
| 72205-184-60 | Darunavir | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72205-184 | DARUNAVIR TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] | 1 | Current NDC, 1 package rows | 20231202_ea6e0136-75b2-4793-9500-04e6658a0a73.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72205-184-60 | 72205018460 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72205-184-60) | 2023-11-29 | No | No | Current |