DARUNAVIR
- Product NDC
- 68180-346
- 11-digit product format
- 681800346
- Labeler code
- 68180
- Product ID
- 68180-346_f2b03ba0-704c-447a-a7ab-b4eb00243295
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DARUNAVIR
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA202073
- Marketing category
- ANDA
- Marketing start
- 2023-06-01
- Substance
- DARUNAVIR ETHANOLATE
- 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 ETHANOLATE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33O78XF0BW |
| Rxcui | 670026, 1359269 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-346-06 | DARUNAVIR | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-346 | DARUNAVIR TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 23 | Current NDC, 1 package rows | 20240320_56daf67e-7501-4cd5-be22-566d7997d42e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68180-346-06 | 68180034606 | 30 TABLET, FILM COATED in 1 BOTTLE (68180-346-06) | 2023-06-01 | No | No | Current |