Ambrisentan
- Product NDC
- 76282-685
- 11-digit product format
- 762820685
- Labeler code
- 76282
- Product ID
- 76282-685_aefcc624-7481-4401-af7a-bd75045b7e60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ambrisentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals, Inc.
- Application
- ANDA210715
- Marketing category
- ANDA
- Marketing start
- 2020-07-22
- Marketing end
- 0000-00-00
- Substance
- AMBRISENTAN
- Active strength
- 10 mg/1
- Pharmacologic classes
- Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-685 | AMBRISENTAN TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | Legacy NDC | 20200723_7e8e16a1-9a35-4370-9291-494808fa3018.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76282-685-30 | 76282068530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76282-685-30) | 2020-07-22 | 0000-00-00 | No | No | Current |