Bosentan
- Product NDC
- 49884-059
- 11-digit product format
- 498840059
- Labeler code
- 49884
- Product ID
- 49884-059_f84703d1-3078-4784-801d-35d80f416a3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bosentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA205699
- Marketing category
- ANDA
- Marketing start
- 2019-04-29
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- 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 |
|---|
| 49884-059-02 | 49884005902 | 60 TABLET, FILM COATED in 1 CONTAINER (49884-059-02) | 2019-04-29 | 0000-00-00 | No | No | Current |