Ambrisentan
- Product NDC
- 0591-2406
- 11-digit product format
- 005912406
- Labeler code
- 0591
- Product ID
- 0591-2406_67758125-7c3e-4b62-8cb3-e17d7f079322
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ambrisentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA208252
- Marketing category
- ANDA
- Marketing start
- 2019-04-30
- Substance
- AMBRISENTAN
- Active strength
- 10 mg/1
- Pharmacologic classes
- Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ambrisentan
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMBRISENTAN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HW6NV07QEC |
| Rxcui | 722116, 722122 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-2406-30 | Ambrisentan | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2406 | AMBRISENTAN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 16 | Current NDC, Legacy NDC, 1 package rows | 20250124_32549c43-f8ff-422c-b42d-ca0877e661cf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2406-30 | 00591240630 | 30 TABLET, FILM COATED in 1 BOTTLE (0591-2406-30) | 2019-04-30 | 0000-00-00 | No | No | Current |