ambrisentan
- Product NDC
- 59651-495
- 11-digit product format
- 596510495
- Labeler code
- 59651
- Product ID
- 59651-495_a6d48e99-4411-4724-8372-b01692a5dff7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ambrisentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA216531
- Marketing category
- ANDA
- Marketing start
- 2022-07-21
- Substance
- AMBRISENTAN
- Active strength
- 10 mg/1
- Pharmacologic classes
- Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ambrisentan
- Listing expiration
- 2026-12-31
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 |
|---|
| 59651-495-30 | ambrisentan | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-495 | AMBRISENTAN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250503_82e51c75-fb78-4ad3-8bce-5e0581d60014.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 |
|---|
| 59651-495-30 | 59651049530 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-495-30) | 2022-07-21 | 0000-00-00 | No | No | Current |