Bosentan
- Product NDC
- 0054-0521
- 11-digit product format
- 000540521
- Labeler code
- 0054
- Product ID
- 0054-0521_03c560f4-2afd-4b15-9466-cff8a3627610
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bosentan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- West-Ward Pharmaceuticals Corp.
- Application
- ANDA208695
- Marketing category
- ANDA
- Marketing start
- 2019-06-04
- Marketing end
- 0000-00-00
- Substance
- BOSENTAN
- Active strength
- 125 mg/1
- Pharmacologic classes
- Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0521-21 | 00054052121 | 60 TABLET in 1 BOTTLE (0054-0521-21) | 60 tablet | 2019-06-04 | 0000-00-00 | No | No | Current |