FDA.reportPublic FDA data

Nucynta 100 MG Oral Tablet

RxCUI
854140
RxNorm name
Nucynta 100 MG Oral Tablet
Display name
Nucynta 100 MG Oral Tablet
Full name
Nucynta 100 MG Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

RxNav Current And Historical NDCs#

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UNII Substances#

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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
NucyntaTAPENTADOL HYDROCHLORIDECollegium Pharmaceutical, Inc.80938c30-9fe3-4c7d-9d9c-5476638cfb2d2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854140

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
80938c30-9fe3-4c7d-9d9c-5476638cfb2dNUCYNTA 100 MG Oral Tablet [PSN] · tapentadol 100 MG Oral Tablet [Nucynta] [SBD] · Nucynta 100 MG Oral Tablet [SY]37These highlights do not include all the information needed to use NUCYNTA ® TABLETS safely and effectively. See full prescribing information for NUCYNTA ® TABLETS. NUCYNTA ® (tapentadol) tablets for oral use C-II Initial U.S. Approval: 200820251230
ad05d6a0-addc-46e9-a5bd-7892b262b090NUCYNTA 100 MG Oral Tablet [PSN] · tapentadol 100 MG Oral Tablet [Nucynta] [SBD] · Nucynta 100 MG Oral Tablet [SY]35These highlights do not include all the information needed to use NUCYNTA ® TABLETS safely and effectively. See full prescribing information for NUCYNTA ® TABLETS. NUCYNTA ® (tapentadol) tablets for oral use C-II Initial U.S. Approval: 200820181207
4a6953cd-9d64-4443-b7db-5aef2c81324dNUCYNTA 100 MG Oral Tablet [PSN] · tapentadol 100 MG Oral Tablet [Nucynta] [SBD] · Nucynta 100 MG Oral Tablet [SY]32These highlights do not include all the information needed to use NUCYNTA® safely and effectively. See full prescribing information for NUCYNTA®. NUCYNTA® (tapentadol) immediate-release oral tablets C-II Initial U.S. Approval: 200820100324
e35e8385-db1f-41a8-8307-20979569ac72NUCYNTA 100 MG Oral Tablet [PSN] · tapentadol 100 MG Oral Tablet [Nucynta] [SBD] · Nucynta 100 MG Oral Tablet [SY]32These highlights do not include all the information needed to use NUCYNTA™ safely and effectively. See full prescribing information for NUCYNTA™. NUCYNTA™ (tapentadol) immediate-release oral tablets C-II Initial U.S. Approval: 200820091027