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
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 49884-059 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 49884-059 | 49884-059-02 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A205699-001 | BOSENTAN | BOSENTAN | 62.5MG | TABLET / ORAL | | | 2019-04-26 |
| A205699-002 | BOSENTAN | BOSENTAN | 125MG | TABLET / ORAL | | | 2019-04-26 |
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 |