FDA.reportPublic FDA data

NDC 59148-089-07 - Jynarque

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
59148-089
Requested NDC
59148-089-07
Package NDCs from labels
59148-089-07, 59148-089-28
Manufacturer
Otsuka America Pharmaceutical, Inc. | Otsuka Pharmaceutical Co Ltd | Boston Analytical Inc | AndersonBrecon Inc | Eurofins Lancaster Laboratories, Inc | Sharp Packaging Services, LLC
Effective date
2026-09-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
JynarqueOtsuka America Pharmaceutical, Inc. | Otsuka Pharmaceutical Co Ltd | Boston Analytical Inc | AndersonBrecon Inc | Eurofins Lancaster Laboratories, Inc | Sharp Packaging Services, LLC2026-09-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59148-089-07Jynarque1 in 1 BLISTER PACKKIT119
59148-089-28Jynarque4 in 1 CARTONKIT419

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59148-089JYNARQUE (TOLVAPTAN) KIT JYNARQUE (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]18Current NDC, Legacy NDC, 2 package rows20250508_3febc0a1-9e5a-4ce0-843d-210f21d862c4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-089-07EA - Each59148-08918346bc9-aa63-45c3-94ec-57efc8db190112018-05-09
59148-089-28EA - Each59148-089a988b730-d8c3-4f04-9c04-5d29047e817d12018-05-09

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 ยท 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TolvaptanTOLVAPTANAscend Laboratories, LLC82ef58ef-ce46-434e-bf99-89fce51094f12026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2719337
rxcui: 2044966
rxcui: 2274815
rxcui: 2719335
rxcui: 2044359
rxcui: 2274813
rxcui: 2044367
rxcui: 2044968
rxcui: 2044970
rxcui: 2044363
unii: 21G72T1950
TolvaptanTOLVAPTANPar Health USA, LLC5b14ba2b-9f80-41d6-9613-f16d3cf37d252026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950
SAMSCATOLVAPTANOtsuka America Pharmaceutical, Inc.5526617c-c7b9-4556-886d-729bbabbc5662026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950
TOLVAPTANTOLVAPTANNorthstar Rx LLCc075d517-f4c8-469a-9f51-416ef61c6a832026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
JynarqueTOLVAPTANOtsuka America Pharmaceutical, Inc.3febc0a1-9e5a-4ce0-843d-210f21d862c42025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA204441
ndc (package): 59148-088-28
ndc (package): 59148-080-28
ndc (package): 59148-079-28
ndc (package): 59148-089-07
ndc (package): 59148-089-28
ndc (package): 59148-087-28
ndc (package): 59148-082-13
ndc (package): 59148-080-07
ndc (package): 59148-083-13
ndc (package): 59148-088-07
ndc (package): 59148-087-07
ndc (package): 59148-079-07
ndc (product): 59148-087
ndc (product): 59148-083
ndc (product): 59148-088
ndc (product): 59148-082
ndc (product): 59148-079
ndc (product): 59148-080
ndc (product): 59148-089
ndc11 (package): 59148008907
rxcui: 2044355
rxcui: 2719337
rxcui: 2044966
rxcui: 2274815
rxcui: 2719335
rxcui: 2044359
rxcui: 2044357
rxcui: 2274813
rxcui: 2044367
rxcui: 2044968
rxcui: 2044971
rxcui: 2044361
rxcui: 2044369
rxcui: 2274816
rxcui: 2044967
rxcui: 2044365
rxcui: 2044969
rxcui: 2044970
rxcui: 2274814
rxcui: 2044363
spl id: 3be8a6fe-a8d0-43ca-a84d-183b522a3cf4
spl set id: 3febc0a1-9e5a-4ce0-843d-210f21d862c4
unii: 21G72T1950
TOLVAPTANTOLVAPTANLupin Pharmaceuticals, Inc.9ba38e23-ca66-4406-92af-bbb8fad00e162025-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2719337
rxcui: 2044966
rxcui: 2274815
rxcui: 2719335
rxcui: 2044359
rxcui: 2274813
rxcui: 2044367
rxcui: 2044968
rxcui: 2044970
rxcui: 2044363
unii: 21G72T1950
TolvaptanTOLVAPTANTeva Pharmaceuticals, Inc.808a9a1f-2f58-4677-9127-e749ad0070942025-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2719337
rxcui: 2044966
rxcui: 2274815
rxcui: 2719335
rxcui: 2044359
rxcui: 2274813
rxcui: 2044367
rxcui: 2044968
rxcui: 2044970
rxcui: 2044363
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
TOLVAPTANTOLVAPTANNovadoz Pharmaceuticals LLC92ce12f1-eae0-4c83-9a4e-a5181e08fa922023-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950
TolvaptanTOLVAPTANAscend Laboratories, LLCdd71ee70-9435-4715-bee5-edbb5a8d7d7b2022-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2044363
unii: 21G72T1950
TolvaptanTOLVAPTANCamber Pharmaceuticals, Inc.6f4c5679-8490-45ec-bd34-1a569e3af8502022-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950

Reported adverse events (FAERS/openFDA)#

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