bosentan
- Product NDC
- 70771-1908
- 11-digit product format
- 707711908
- Labeler code
- 70771
- Product ID
- 70771-1908_008fc213-caa0-4d52-9ee2-e3628c19b90b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bosentan
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA213981
- Marketing category
- ANDA
- Marketing start
- 2026-02-17
- Substance
- BOSENTAN
- Active strength
- 32 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- bosentan
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BOSENTAN | 32 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q326023R30 |
| Rxcui | 1989081 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1908-7 | bosentan | 14 in 1 BLISTER PACK | TABLET, FOR SUSPENSION | 14 | | 1 |
| 70771-1908-8 | bosentan | 4 in 1 CARTON | TABLET, FOR SUSPENSION | 4 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1908-7 | 70771190807 | 14 in 1 BLISTER PACK | | | | | Historical |
| 70771-1908-8 | 70771190808 | 4 BLISTER PACK in 1 CARTON (70771-1908-8) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70771-1908-7) | 4 blister pack | 2026-02-17 | No | No | Current |