Bosentan
- Product NDC
- 46708-383
- 11-digit product format
- 467080383
- Labeler code
- 46708
- Product ID
- 46708-383_e67f1476-1394-4c2c-b03e-a80d0d4da5cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bosentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA211461
- Marketing category
- ANDA
- Marketing start
- 2020-01-24
- Marketing end
- 0000-00-00
- Substance
- BOSENTAN
- Active strength
- 63 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-383-10 | 46708038310 | 100 TABLET, FILM COATED in 1 CARTON (46708-383-10) | 2020-01-24 | 0000-00-00 | No | No | Current |
| 46708-383-60 | 46708038360 | 60 TABLET, FILM COATED in 1 BOTTLE (46708-383-60) | 2020-01-24 | 0000-00-00 | No | No | Current |