Darunavir
- Product NDC
- 31722-567
- 11-digit product format
- 317220567
- Labeler code
- 31722
- Product ID
- 31722-567_06f285d0-a267-615d-e063-6394a90a68ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darunavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA202083
- Marketing category
- ANDA
- Marketing start
- 2023-09-14
- Substance
- DARUNAVIR
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YO603Y8113 |
| Rxcui | 670026, 824338 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-567-60 | Darunavir | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-567 | DARUNAVIR (DARUNAVIR) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20231005_64160982-e682-4e8d-8800-a89321112211.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-567-60 | 31722056760 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-567-60) | 2023-09-14 | No | No | Current |