Bosentan
- Product NDC
- 47781-271
- 11-digit product format
- 477810271
- Labeler code
- 47781
- Product ID
- 47781-271_0a41ac89-9363-4711-474d-2eef59296631
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bosentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alvogen Inc.
- Application
- ANDA206002
- Marketing category
- ANDA
- Marketing start
- 2019-04-26
- Marketing end
- 2022-05-01
- 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
- 0000-00-00
- 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 | 47781-271 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 47781-271 | 47781-271-60 | 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 |
|---|
| A206002-001 | BOSENTAN | BOSENTAN | 62.5MG | TABLET / ORAL | | | 2019-04-26 |
| A206002-002 | 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 |
|---|
| 47781-271-60 | 47781027160 | 60 TABLET, FILM COATED in 1 BOTTLE (47781-271-60) | 2019-04-26 | 0000-00-00 | No | No | Current |