bosentan
- Product NDC
- 0591-2512
- 11-digit product format
- 005912512
- Labeler code
- 0591
- Product ID
- 0591-2512_8f3d0f83-84b4-4860-9478-c86488f41001
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bosentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA207110
- Marketing category
- ANDA
- Marketing start
- 2019-06-19
- Substance
- BOSENTAN
- Active strength
- 125 mg/1
- Pharmacologic classes
- Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- bosentan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BOSENTAN | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q326023R30 |
| Rxcui | 349253, 656659 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-2512-60 | bosentan | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2512 | BOSENTAN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 20 | Current NDC, Legacy NDC, 1 package rows | 20240423_39b2a85f-4322-42d4-b420-1b1d52569143.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2512-60 | 00591251260 | 60 TABLET, FILM COATED in 1 BOTTLE (0591-2512-60) | 2019-06-19 | 0000-00-00 | No | No | Current |