FDA.reportPublic FDA data

TOLVAPTAN - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2024-07-30
Label type
Indexing - Product Concept
Version
5
Source
full-release
Hydrated at
2026-06-05 00:24:07

Label at a glance#

ProductTOLVAPTAN
Active ingredientTOLVAPTAN

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLVAPTAN21G72T1950ACTIB
TOLVAPTAN21G72T1950ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TolvaptanTOLVAPTANAscend Laboratories, LLC82ef58ef-ce46-434e-bf99-89fce51094f12026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tolvaptan
generic name: TOLVAPTAN
TolvaptanTOLVAPTANPar Health USA, LLC5b14ba2b-9f80-41d6-9613-f16d3cf37d252026-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tolvaptan
generic name: TOLVAPTAN
SAMSCATOLVAPTANOtsuka America Pharmaceutical, Inc.5526617c-c7b9-4556-886d-729bbabbc5662026-05-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOLVAPTAN
TOLVAPTANTOLVAPTANNorthstar Rx LLCc075d517-f4c8-469a-9f51-416ef61c6a832026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOLVAPTAN
generic name: TOLVAPTAN
TOLVAPTANTOLVAPTANLupin Pharmaceuticals, Inc.9ba38e23-ca66-4406-92af-bbb8fad00e162025-05-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOLVAPTAN
generic name: TOLVAPTAN
TolvaptanTOLVAPTANTeva Pharmaceuticals, Inc.808a9a1f-2f58-4677-9127-e749ad0070942025-03-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tolvaptan
generic name: TOLVAPTAN
TOLVAPTANTOLVAPTANNovadoz Pharmaceuticals LLC92ce12f1-eae0-4c83-9a4e-a5181e08fa922023-06-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOLVAPTAN
generic name: TOLVAPTAN
TolvaptanTOLVAPTANAscend Laboratories, LLCdd71ee70-9435-4715-bee5-edbb5a8d7d7b2022-09-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tolvaptan
generic name: TOLVAPTAN
TolvaptanTOLVAPTANCamber Pharmaceuticals, Inc.6f4c5679-8490-45ec-bd34-1a569e3af8502022-09-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tolvaptan
generic name: TOLVAPTAN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.