FDA.reportPublic FDA data

{28 (tolvaptan 30 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 60 MG Oral Tablet [Jynarque]) } Pack [Jynarque 60/30 Carton]

RxCUI
2044967
RxNorm name
{28 (tolvaptan 30 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 60 MG Oral Tablet [Jynarque]) } Pack [Jynarque 60/30 Carton]
Display name
{28 (tolvaptan 30 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 60 MG Oral Tablet [Jynarque]) } Pack [Jynarque 60/30 Carton]
Full name
{28 (tolvaptan 30 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 60 MG Oral Tablet [Jynarque]) } Pack [Jynarque 60/30 Carton]
Term type
BPCK
Status
DailyMed mapping
Updated
2026-06-04 23:38:55

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JynarqueTOLVAPTANOtsuka America Pharmaceutical, Inc.3febc0a1-9e5a-4ce0-843d-210f21d862c42025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2044967

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3febc0a1-9e5a-4ce0-843d-210f21d862c4{28 (tolvaptan 30 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 60 MG Oral Tablet [Jynarque]) } Pack [Jynarque 60/30 Carton] [BPCK] · JYNARQUE 60 MG / 30 MG Carton Pack [PSN] · 4 {7 (tolvaptan 60 MG Oral Tablet [Jynarque]) / 7 (tolvaptan 30 MG Oral Tablet [Jynarque]) } Pack [Jynarque 60/30 Carton] [SY] · Jynarque 60 MG / 30 MG Carton Pack [SY] · Jynarque 60 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Capsules Each [SY]519These highlights do not include all the information needed to use JYNARQUE safely and effectively. See full prescribing information for JYNARQUE. JYNARQUE ® (tolvaptan) tablets, for oral use Initial U.S. Approval: 200920251106