FDA.reportPublic FDA data

Nucynta 100 MG (tapentadol hydrochloride 116.48 MG) 12 HR Extended Release Oral Tablet

RxCUI
1149367
RxNorm name
Nucynta 100 MG (tapentadol hydrochloride 116.48 MG) 12 HR Extended Release Oral Tablet
Display name
Nucynta 100 MG (tapentadol hydrochloride 116.48 MG) 12 HR Extended Release Oral Tablet
Full name
Nucynta 100 MG (tapentadol hydrochloride 116.48 MG) 12 HR Extended Release Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

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
Nucynta ERTAPENTADOL HYDROCHLORIDECollegium Pharmaceutical, Inc.c3d04d70-0155-4147-9ce4-a3b1fad4b3732025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1149367

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
c3d04d70-0155-4147-9ce4-a3b1fad4b373Nucynta ER 100 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR tapentadol 100 MG Extended Release Oral Tablet [Nucynta] [SBD] · 12 HR Nucynta 100 MG Extended Release Oral Tablet [SY] · Nucynta 100 MG (tapentadol hydrochloride 116.48 MG) 12 HR Extended Release Oral Tablet [SY]48These highlights do not include all the information needed to use NUCYNTA ® ER safely and effectively. See full prescribing information for NUCYNTA ® ER NUCYNTA ® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 200820251230
40671852-846e-4bc1-8e15-1f71add24414Nucynta ER 100 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR tapentadol 100 MG Extended Release Oral Tablet [Nucynta] [SBD] · 12 HR Nucynta 100 MG Extended Release Oral Tablet [SY] · Nucynta 100 MG (tapentadol hydrochloride 116.48 MG) 12 HR Extended Release Oral Tablet [SY]45These highlights do not include all the information needed to use NUCYNTA ® ER safely and effectively. See full prescribing information for NUCYNTA ® ER NUCYNTA ® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 200820181022