Basic Information
Nucynta ER
24510-291
Regulatory Information
24510-291
NDA200533
C73594
December 20, 2023
USA
These 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: 2008
HUMAN PRESCRIPTION DRUG LABEL
7
Company Information
032531241
Active Ingredients
TALC
Code: 7SEV7J4R1U
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
ALUMINUM OXIDE
Code: LMI26O6933
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
.ALPHA.-TOCOPHEROL
Code: H4N855PNZ1
Class Code: IACT
POLYVINYL ALCOHOL, UNSPECIFIED
Code: 532B59J990
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
Active Moieties
TAPENTADOL
Code: H8A007M585