Bosentan
- Product NDC
- 68180-340
- 11-digit product format
- 681800340
- Labeler code
- 68180
- Product ID
- 68180-340_063d2028-f666-4304-8cd3-21d882d8c97f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bosentan
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA213154
- Marketing category
- ANDA
- Marketing start
- 2025-08-18
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| Q326023R30 | BOSENTAN | 157212-55-0 | BOSENTAN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68180-340-13 | 68180034013 | 4 BLISTER PACK in 1 CARTON (68180-340-13) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK | 4 blister pack | 2025-08-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Bosentan | Lupin Pharmaceuticals, Inc. | 2025-11-03 | Human Prescription Drug Label | 7 |
| Bosentan | Lupin Pharmaceuticals, Inc. | 2025-06-07 | Human Prescription Drug Label | 6 |
| Bekyree | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2023-03-31 | HUMAN PRESCRIPTION DRUG LABEL | 4 |