NDC 59148-079

Jynarque

Tolvaptan

Jynarque is a Kit in the Human Prescription Drug category. It is labeled and distributed by Otsuka America Pharmaceutical, Inc.. The primary component is .

Product ID59148-079_1c7d17da-0b48-425b-949a-6f90bfd3a71c
NDC59148-079
Product TypeHuman Prescription Drug
Proprietary NameJynarque
Generic NameTolvaptan
Dosage FormKit
Marketing Start Date2020-01-13
Marketing CategoryNDA / NDA
Application NumberNDA204441
Labeler NameOtsuka America Pharmaceutical, Inc.
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 59148-079-28

4 BLISTER PACK in 1 CARTON (59148-079-28) > 1 KIT in 1 BLISTER PACK (59148-079-07)
Marketing Start Date2020-01-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59148-079-28 [59148007928]

Jynarque KIT
Marketing CategoryNDA
Application NumberNDA204441
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-31

NDC 59148-079-07 [59148007907]

Jynarque KIT
Marketing CategoryNDA
Application NumberNDA204441
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-31

Drug Details

OpenFDA Data

SPL SET ID:3febc0a1-9e5a-4ce0-843d-210f21d862c4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2044369
  • 849827
  • 2274814
  • 2274816
  • 2274813
  • 2044361
  • 2044363
  • 2044365
  • 2274815
  • 2044367
  • 2044355
  • 2044357
  • 2044966
  • 2044967
  • 2044971
  • 2044968
  • 2044969
  • 2044359
  • 2044970
  • 849833
    • UPC Code
  • 0359148080284
  • 0359148088075
  • 0359148082134
  • 0359148083131
  • 0359148087283
  • 0359148079288
  • 0359148089287
  • 0359148080079
  • 0359148087078
  • 0359148088280
  • 0359148089072
  • 0359148079073

    • 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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