NDC 60505-4704

TOLVAPTAN

Tolvaptan

TOLVAPTAN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Tolvaptan.

Product ID60505-4704_4c0980e3-055c-4876-be1b-44e655bfda02
NDC60505-4704
Product TypeHuman Prescription Drug
Proprietary NameTOLVAPTAN
Generic NameTolvaptan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-10-15
Marketing CategoryNDA / NDA
Application NumberNDA022275
Labeler NameApotex Corp.
Substance NameTOLVAPTAN
Active Ingredient Strength15 mg/1
Pharm ClassesVasopressin V2 Receptor Antagonist [EPC],Vasopressin V2 Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 60505-4704-0

1 BLISTER PACK in 1 CARTON (60505-4704-0) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2019-09-01
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
TOLVAPTAN15 mg/1

OpenFDA Data

SPL SET ID:ebae8c22-2abf-4b81-9bab-e068e798af48
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849827
  • 849833
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    60505-4704TOLVAPTANtolvaptan
    60505-4705TOLVAPTANtolvaptan
    67877-636TolvaptanTolvaptan
    67877-637TolvaptanTolvaptan
    59148-079Jynarquetolvaptan
    59148-080Jynarquetolvaptan
    59148-082JYNARQUEtolvaptan
    59148-083JYNARQUEtolvaptan
    59148-087Jynarquetolvaptan
    59148-088Jynarquetolvaptan
    59148-089Jynarquetolvaptan
    59148-020SAMSCAtolvaptan
    59148-021SAMSCAtolvaptan

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