Darunavir
- Product NDC
- 43598-704
- 11-digit product format
- 435980704
- Labeler code
- 43598
- Product ID
- 43598-704_82f022df-8075-b1cd-f33b-a5603365dcc2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darunavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr.Reddys Laboratories Inc
- Application
- ANDA211578
- Marketing category
- ANDA
- Marketing start
- 2023-11-29
- 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 |
|---|
| 43598-704-05 | Darunavir | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 7 |
| 43598-704-60 | Darunavir | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-704 | DARUNAVIR TABLET, FILM COATED [DR.REDDYS LABORATORIES INC] | 7 | Current NDC, 2 package rows | 20231201_f5c9cb01-6530-4db0-a326-22a499d1efdf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-704-05 | 43598070405 | 500 TABLET, FILM COATED in 1 BOTTLE (43598-704-05) | 2023-11-29 | No | No | Current |
| 43598-704-60 | 43598070460 | 60 TABLET, FILM COATED in 1 BOTTLE (43598-704-60) | 2023-11-29 | No | No | Current |