Ambrisentan
- Product NDC
- 70771-1364
- 11-digit product format
- 707711364
- Labeler code
- 70771
- Product ID
- 70771-1364_14a85c38-61bf-4621-8e3a-34ab57a15758
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ambrisentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA210058
- Marketing category
- ANDA
- Marketing start
- 2019-04-12
- 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 |
|---|
| 70771-1364-1 | Ambrisentan | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 10 |
| 70771-1364-3 | Ambrisentan | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
| 70771-1364-7 | Ambrisentan | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 10 |
| 70771-1364-7 | Ambrisentan | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 10 |
| 70771-1364-8 | Ambrisentan | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 10 |
| 70771-1364-8 | Ambrisentan | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 10 |
| 70771-1364-9 | 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 |
|---|
| 70771-1364 | AMBRISENTAN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 10 | Current NDC, Legacy NDC, 7 package rows | 20241127_0e3e3320-27ac-404f-9f01-3d82696e768a.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 |
|---|
| 70771-1364-1 | 70771136401 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1364-1) | | 2019-04-12 | 0000-00-00 | No | No | Current |
| 70771-1364-3 | 70771136403 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1364-3) | | 2019-04-12 | 0000-00-00 | No | No | Current |
| 70771-1364-7 | 70771136407 | 1 BLISTER PACK in 1 CARTON (70771-1364-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2019-04-12 | 0000-00-00 | No | No | Current |
| 70771-1364-8 | 70771136408 | 3 BLISTER PACK in 1 CARTON (70771-1364-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 3 blister pack | 2019-04-12 | 0000-00-00 | No | No | Current |
| 70771-1364-9 | 70771136409 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1364-9) | | 2019-04-12 | 0000-00-00 | No | No | Current |