FDA.reportPublic FDA data

tapentadol 250 MG 12HR Extended Release Oral Tablet

RxCUI
1148807
RxNorm name
tapentadol 250 MG 12HR Extended Release Oral Tablet
Display name
tapentadol 250 MG 12HR Extended Release Oral Tablet
Full name
tapentadol 250 MG 12HR Extended Release Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TAPENTADOLTAPENTADOL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.38de863e-56ff-4c43-9ab8-9b3e1ba828582026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1148807
Nucynta ERTAPENTADOL HYDROCHLORIDECollegium Pharmaceutical, Inc.c3d04d70-0155-4147-9ce4-a3b1fad4b3732025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1148807

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
c3d04d70-0155-4147-9ce4-a3b1fad4b373tapentadol 250 MG 12HR Extended Release Oral TabletPSN8These 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
c3d04d70-0155-4147-9ce4-a3b1fad4b37312 HR tapentadol 250 MG Extended Release Oral TabletSCD8These 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-4bc1-8e15-1f71add24414tapentadol 250 MG 12HR Extended Release Oral TabletPSN5These 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
40671852-846e-4bc1-8e15-1f71add2441412 HR tapentadol 250 MG Extended Release Oral TabletSCD5These 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
38de863e-56ff-4c43-9ab8-9b3e1ba82858tapentadol 250 MG 12HR Extended Release Oral TabletPSN3These highlights do not include all the information needed to use Tapentadol extended-release tablets safely and effectively. See full prescribing information for tapentadol extended-release tablet Tapentadol extended-release tablet for oral use C-II Initial U.S. Approval: 200820260226
38de863e-56ff-4c43-9ab8-9b3e1ba8285812 HR tapentadol 250 MG Extended Release Oral TabletSCD3These highlights do not include all the information needed to use Tapentadol extended-release tablets safely and effectively. See full prescribing information for tapentadol extended-release tablet Tapentadol extended-release tablet for oral use C-II Initial U.S. Approval: 200820260226