Ambrisentan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Ambrisentan.
| Product ID | 70710-1179_18d85ac0-9b44-49a9-8a8b-81005dc7977d |
| NDC | 70710-1179 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ambrisentan |
| Generic Name | Ambrisentan |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-04-12 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA210058 |
| Labeler Name | Zydus Pharmaceuticals (USA) Inc. |
| Substance Name | AMBRISENTAN |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2019-04-12 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA210058 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-12 |
| Marketing Category | ANDA |
| Application Number | ANDA210058 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-12 |
| Marketing Category | ANDA |
| Application Number | ANDA210058 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-12 |
| Marketing Category | ANDA |
| Application Number | ANDA210058 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-04-12 |
| Marketing Category | ANDA |
| Application Number | ANDA210058 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-12 |
| Ingredient | Strength |
|---|---|
| AMBRISENTAN | 5 mg/1 |
| SPL SET ID: | 37af3191-0ed3-4783-8747-065f1462f2d2 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-4270 | Ambrisentan | ambrisentan |
| 0378-4271 | Ambrisentan | ambrisentan |
| 0591-2405 | Ambrisentan | Ambrisentan |
| 0591-2406 | Ambrisentan | Ambrisentan |
| 42291-018 | AMBRISENTAN | AMBRISENTAN |
| 42291-019 | AMBRISENTAN | AMBRISENTAN |
| 42794-051 | AMBRISENTAN | AMBRISENTAN |
| 42794-052 | AMBRISENTAN | AMBRISENTAN |
| 47335-236 | ambrisentan | ambrisentan |
| 47335-237 | ambrisentan | ambrisentan |
| 49884-353 | Ambrisentan | Ambrisentan |
| 49884-354 | Ambrisentan | Ambrisentan |
| 59651-494 | ambrisentan | ambrisentan |
| 59651-495 | ambrisentan | ambrisentan |
| 60505-4552 | Ambrisentan | AMBRISENTAN |
| 60505-4553 | Ambrisentan | AMBRISENTAN |
| 69097-386 | Ambrisentan | Ambrisentan |
| 69097-387 | Ambrisentan | Ambrisentan |
| 70710-1179 | Ambrisentan | Ambrisentan |
| 70710-1180 | Ambrisentan | Ambrisentan |
| 70771-1363 | Ambrisentan | Ambrisentan |
| 70771-1364 | Ambrisentan | Ambrisentan |
| 76282-684 | Ambrisentan | Ambrisentan |
| 76282-685 | Ambrisentan | Ambrisentan |
| 61958-0801 | Letairis | AMBRISENTAN |
| 61958-0802 | Letairis | AMBRISENTAN |