Tolvaptan is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ascend Laboratories, Llc. The primary component is Tolvaptan.
| Product ID | 67877-637_b6c02c7f-5141-477b-9c07-c6473a9c79fc |
| NDC | 67877-637 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Tolvaptan |
| Generic Name | Tolvaptan |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-05-21 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA211891 |
| Labeler Name | Ascend Laboratories, LLC |
| Substance Name | TOLVAPTAN |
| Active Ingredient Strength | 60 mg/1 |
| Pharm Classes | Vasopressin V2 Receptor Antagonist [EPC],Vasopressin V2 Receptor Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-05-21 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA211891 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-05-21 |
| Marketing Category | ANDA |
| Application Number | ANDA211891 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-05-21 |
| Marketing Category | ANDA |
| Application Number | ANDA211891 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-05-21 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 31722-868 | Tolvaptan | Tolvaptan |
| 31722-869 | Tolvaptan | Tolvaptan |
| 49884-768 | Tolvaptan | Tolvaptan |
| 49884-770 | Tolvaptan | Tolvaptan |
| 60505-4704 | TOLVAPTAN | TOLVAPTAN |
| 60505-4705 | TOLVAPTAN | TOLVAPTAN |
| 67877-636 | Tolvaptan | Tolvaptan |
| 67877-637 | Tolvaptan | Tolvaptan |
| 59148-079 | Jynarque | tolvaptan |
| 59148-080 | Jynarque | tolvaptan |
| 59148-082 | JYNARQUE | tolvaptan |
| 59148-083 | JYNARQUE | tolvaptan |
| 59148-087 | Jynarque | tolvaptan |
| 59148-088 | Jynarque | tolvaptan |
| 59148-020 | SAMSCA | tolvaptan |
| 59148-021 | SAMSCA | tolvaptan |