Ambrisentan
- Product NDC
- 70710-1179
- 11-digit product format
- 707101179
- Labeler code
- 70710
- Product ID
- 70710-1179_4ad0e26d-a3b2-47d1-89a0-6e7e0697d5e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ambrisentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA210058
- Marketing category
- ANDA
- Marketing start
- 2019-04-12
- Substance
- AMBRISENTAN
- Active strength
- 5 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 | 5 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 |
|---|
| 70710-1179-1 | Ambrisentan | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 10 |
| 70710-1179-3 | Ambrisentan | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
| 70710-1179-7 | Ambrisentan | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 10 |
| 70710-1179-7 | Ambrisentan | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 10 |
| 70710-1179-8 | Ambrisentan | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 10 |
| 70710-1179-8 | Ambrisentan | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 10 |
| 70710-1179-9 | Ambrisentan | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1179 | AMBRISENTAN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 10 | Current NDC, Legacy NDC, 7 package rows | 20250424_37af3191-0ed3-4783-8747-065f1462f2d2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70710-1179-1 | 70710117901 | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1179-1) | | 2019-04-12 | 0000-00-00 | No | No | Current |
| 70710-1179-3 | 70710117903 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1179-3) | | 2019-04-12 | 0000-00-00 | No | No | Current |
| 70710-1179-7 | 70710117907 | 1 BLISTER PACK in 1 CARTON (70710-1179-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2019-04-12 | 0000-00-00 | No | No | Current |
| 70710-1179-8 | 70710117908 | 3 BLISTER PACK in 1 CARTON (70710-1179-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 3 blister pack | 2019-04-12 | 0000-00-00 | No | No | Current |
| 70710-1179-9 | 70710117909 | 90 TABLET, FILM COATED in 1 BOTTLE (70710-1179-9) | | 2019-04-12 | 0000-00-00 | No | No | Current |