Bosentan
- Product NDC
- 47335-038
- 11-digit product format
- 473350038
- Labeler code
- 47335
- Product ID
- 47335-038_72ab60fc-63c5-4b1e-93ce-a21f3754e343
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bosentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA209324
- Marketing category
- ANDA
- Marketing start
- 2019-04-26
- Substance
- BOSENTAN
- Active strength
- 62.5 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 | 62.5 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 |
|---|
| 47335-038-60 | Bosentan | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | | 9 |
| 47335-038-64 | Bosentan | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 9 |
| 47335-038-86 | Bosentan | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-038 | BOSENTAN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20241018_c006d8ef-8cb7-4fb3-88eb-b2debc302a20.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-038-60 | 47335003860 | 3 in 1 BLISTER PACK | | | | | | Historical |
| 47335-038-64 | 47335003864 | 10 BLISTER PACK in 1 CARTON (47335-038-64) / 3 TABLET, FILM COATED in 1 BLISTER PACK (47335-038-60) | 10 blister pack | 2019-04-26 | 0000-00-00 | No | No | Current |
| 47335-038-86 | 47335003886 | 60 TABLET, FILM COATED in 1 BOTTLE (47335-038-86) | | 2019-04-26 | 0000-00-00 | No | No | Current |