bosentan
- Product NDC
- 10148-625
- 11-digit product format
- 101480625
- Labeler code
- 10148
- Product ID
- 10148-625_445edd1e-6394-11ea-97fe-c235fc2ca371
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bosentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- CoTherix, Inc.
- Application
- NDA021290
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-06-03
- 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 |
|---|
| 10148-625-60 | 10148062560 | 1 BOTTLE, PLASTIC in 1 CARTON (10148-625-60) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2019-06-03 | 0000-00-00 | No | No | Current |