NDC 59148-021
SAMSCA
Tolvaptan
SAMSCA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Otsuka America Pharmaceutical, Inc.. The primary component is Tolvaptan.
| Product ID | 59148-021_17d25d59-6f09-4e2e-9c87-382d4f780e4f |
| NDC | 59148-021 |
| Product Type | Human Prescription Drug |
| Proprietary Name | SAMSCA |
| Generic Name | Tolvaptan |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2009-05-19 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022275 |
| Labeler Name | Otsuka America Pharmaceutical, Inc. |
| Substance Name | TOLVAPTAN |
| Active Ingredient Strength | 30 mg/1 |
| Pharm Classes | Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 59148-021-50
1 BLISTER PACK in 1 CARTON (59148-021-50) > 10 TABLET in 1 BLISTER PACK
| Marketing Start Date | 2009-05-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 59148-021-50 [59148002150]
SAMSCA TABLET
| Marketing Category | NDA |
| Application Number | NDA022275 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-05-19 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| TOLVAPTAN | 30 mg/1 |
OpenFDA Data
| SPL SET ID: | 5526617c-c7b9-4556-886d-729bbabbc566 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Vasopressin V2 Receptor Antagonist [EPC]
- Vasopressin V2 Receptor Antagonists [MoA]
NDC Crossover Matching brand name "SAMSCA" or generic name "Tolvaptan"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 59148-020 | SAMSCA | tolvaptan |
| 59148-021 | SAMSCA | 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 |
| 31722-868 | Tolvaptan | Tolvaptan |
| 31722-869 | Tolvaptan | Tolvaptan |
| 49884-768 | Tolvaptan | Tolvaptan |
| 49884-770 | Tolvaptan | Tolvaptan |
Trademark Results [SAMSCA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAMSCA 76692397 3687896 Live/Registered |
Otsuka Pharmaceutical Co., Ltd. 2008-08-26 |
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