Bosentan
- Product NDC
- 68382-447
- 11-digit product format
- 683820447
- Labeler code
- 68382
- Product ID
- 68382-447_f6180792-cb7a-46ef-b2bb-4a819e4901bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bosentan
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA207760
- Marketing category
- ANDA
- Marketing start
- 2019-05-01
- 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
- 2027-12-31
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 |
|---|
| 68382-447-01 | Bosentan | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 7 |
| 68382-447-05 | Bosentan | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 7 |
| 68382-447-14 | Bosentan | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 7 |
| 68382-447-28 | Bosentan | 180 in 1 BOTTLE | TABLET, COATED | 180 | | 7 |
| 68382-447-30 | Bosentan | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | | 7 |
| 68382-447-77 | Bosentan | 10 in 1 CARTON | TABLET, COATED | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-447 | BOSENTAN TABLET, COATED [ZYDUS PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20240229_8444da17-6c31-492b-8842-93740f083d9d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-447-01 | 68382044701 | 100 TABLET, COATED in 1 BOTTLE (68382-447-01) | | 2019-05-01 | 0000-00-00 | No | No | Current |
| 68382-447-05 | 68382044705 | 500 TABLET, COATED in 1 BOTTLE (68382-447-05) | | 2019-05-01 | 0000-00-00 | No | No | Current |
| 68382-447-14 | 68382044714 | 60 TABLET, COATED in 1 BOTTLE (68382-447-14) | | 2019-05-01 | 0000-00-00 | No | No | Current |
| 68382-447-28 | 68382044728 | 180 TABLET, COATED in 1 BOTTLE (68382-447-28) | | 2019-05-01 | 0000-00-00 | No | No | Current |
| 68382-447-30 | 68382044730 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-447-77 | 68382044777 | 10 BLISTER PACK in 1 CARTON (68382-447-77) / 10 TABLET, COATED in 1 BLISTER PACK (68382-447-30) | 10 blister pack | 2019-05-01 | 0000-00-00 | No | No | Current |