Bosentan
- Product NDC
- 65162-873
- 11-digit product format
- 651620873
- Labeler code
- 65162
- Product ID
- 65162-873_1fb8b35b-4aa6-4ba0-86c1-9e9d1afe31ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bosentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA209742
- Marketing category
- ANDA
- Marketing start
- 2019-04-26
- Marketing end
- 0000-00-00
- Substance
- BOSENTAN ANHYDROUS
- Active strength
- 63 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-873 | BOSENTAN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] | 11 | Legacy NDC | 20241011_dc117215-2304-41c1-ad3c-31d5e1029657.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-873-06 | 65162087306 | 60 TABLET, FILM COATED in 1 BOTTLE (65162-873-06) | 2019-04-26 | 0000-00-00 | No | No | Current |