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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bosentan
- Listing expiration
- 2026-12-31
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 |
|---|
| 68180-340-13 | Bosentan | 14 in 1 BLISTER PACK | TABLET, FOR SUSPENSION | 14 | | 7 |
| 68180-340-13 | Bosentan | 4 in 1 CARTON | TABLET, FOR SUSPENSION | 4 | | 7 |
| 68180-340-74 | Bekyree | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | 0.01 mg | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-340 | BEKYREE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 4 | Current NDC | 20230322_f1fcfd58-880d-4023-b48a-67e87c094f37.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |
| 68180-340-74 | 68180034074 | 5 in 1 BLISTER PACK | | | | | Historical |