NDC 60505-4705

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 ID60505-4705_1bcbe7de-c01b-4ace-b2cf-8d663b3f92ed
NDC60505-4705
Product TypeHuman Prescription Drug
Proprietary NameTOLVAPTAN
Generic NameTolvaptan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-05-20
Marketing CategoryNDA / NDA
Application NumberNDA022275
Labeler NameApotex Corp.
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 60505-4705-0

1 BLISTER PACK in 1 CARTON (60505-4705-0) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2020-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-4705-0 [60505470500]

TOLVAPTAN TABLET
Marketing CategoryNDA
Application NumberNDA022275
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-20

Drug Details

Active Ingredients

IngredientStrength
TOLVAPTAN30 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
    31722-868TolvaptanTolvaptan
    31722-869TolvaptanTolvaptan
    49884-768TolvaptanTolvaptan
    49884-770TolvaptanTolvaptan
    60505-4704TOLVAPTANTOLVAPTAN
    60505-4705TOLVAPTANTOLVAPTAN
    67877-636TolvaptanTolvaptan
    67877-637TolvaptanTolvaptan
    59148-079Jynarquetolvaptan
    59148-080Jynarquetolvaptan
    59148-082JYNARQUEtolvaptan
    59148-083JYNARQUEtolvaptan
    59148-087Jynarquetolvaptan
    59148-088Jynarquetolvaptan
    59148-020SAMSCAtolvaptan
    59148-021SAMSCAtolvaptan

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