NDC 59148-083

JYNARQUE

Tolvaptan

JYNARQUE 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 ID59148-083_1c7d17da-0b48-425b-949a-6f90bfd3a71c
NDC59148-083
Product TypeHuman Prescription Drug
Proprietary NameJYNARQUE
Generic NameTolvaptan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-04-23
Marketing CategoryNDA / NDA
Application NumberNDA204441
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 Through2022-12-31

Packaging

NDC 59148-083-13

1 BOTTLE in 1 CARTON (59148-083-13) > 30 TABLET in 1 BOTTLE
Marketing Start Date2018-04-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59148-083-13 [59148008313]

JYNARQUE TABLET
Marketing CategoryNDA
Application NumberNDA204441
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-23

Drug Details

Active Ingredients

IngredientStrength
TOLVAPTAN30 mg/1

OpenFDA Data

SPL SET ID:3febc0a1-9e5a-4ce0-843d-210f21d862c4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2044369
  • 849827
  • 2044361
  • 2044363
  • 2044365
  • 2044367
  • 2044355
  • 2044357
  • 2044966
  • 2044967
  • 2044971
  • 2044968
  • 2044969
  • 2044359
  • 2044970
  • 849833
  • UPC Code
  • 0359148083131
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    59148-079Jynarquetolvaptan
    59148-080Jynarquetolvaptan
    59148-082JYNARQUEtolvaptan
    59148-083JYNARQUEtolvaptan
    59148-087Jynarquetolvaptan
    59148-088Jynarquetolvaptan
    59148-089JynarqueJynarque
    59148-020SAMSCAtolvaptan
    59148-021SAMSCAtolvaptan
    31722-868TolvaptanTolvaptan
    31722-869TolvaptanTolvaptan
    49884-768TolvaptanTolvaptan
    49884-770TolvaptanTolvaptan

    Trademark Results [JYNARQUE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    JYNARQUE
    JYNARQUE
    87632640 5482786 Live/Registered
    Otsuka Pharmaceutical Co., Ltd.
    2017-10-03

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