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 ID59148-021_17d25d59-6f09-4e2e-9c87-382d4f780e4f
NDC59148-021
Product TypeHuman Prescription Drug
Proprietary NameSAMSCA
Generic NameTolvaptan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-05-19
Marketing CategoryNDA / NDA
Application NumberNDA022275
Labeler NameOtsuka America Pharmaceutical, Inc.
Substance NameTOLVAPTAN
Active Ingredient Strength30 mg/1
Pharm ClassesVasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59148-021-50

1 BLISTER PACK in 1 CARTON (59148-021-50) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2009-05-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59148-021-50 [59148002150]

SAMSCA TABLET
Marketing CategoryNDA
Application NumberNDA022275
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-19

Drug Details

Active Ingredients

IngredientStrength
TOLVAPTAN30 mg/1

OpenFDA Data

SPL SET ID:5526617c-c7b9-4556-886d-729bbabbc566
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849835
  • 849827
  • 849831
  • 849833
  • Pharmacological Class

    • Vasopressin V2 Receptor Antagonist [EPC]
    • Vasopressin V2 Receptor Antagonists [MoA]

    NDC Crossover Matching brand name "SAMSCA" or generic name "Tolvaptan"

    NDCBrand NameGeneric Name
    59148-020SAMSCAtolvaptan
    59148-021SAMSCAtolvaptan
    59148-079Jynarquetolvaptan
    59148-080Jynarquetolvaptan
    59148-082JYNARQUEtolvaptan
    59148-083JYNARQUEtolvaptan
    59148-087Jynarquetolvaptan
    59148-088Jynarquetolvaptan
    31722-868TolvaptanTolvaptan
    31722-869TolvaptanTolvaptan
    49884-768TolvaptanTolvaptan
    49884-770TolvaptanTolvaptan

    Trademark Results [SAMSCA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SAMSCA
    SAMSCA
    76692397 3687896 Live/Registered
    Otsuka Pharmaceutical Co., Ltd.
    2008-08-26

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