Nucynta
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
Approved
Approval ID
40671852-846e-4bc1-8e15-1f71add24414
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 2018
Manufacturers
FDA
Depo NF Sub, LLC
DUNS: 079790476
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tapentadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69865-240
Application NumberNDA200533
Product Classification
M
Marketing Category
C73594
G
Generic Name
tapentadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2018
FDA Product Classification
INGREDIENTS (10)
TAPENTADOL HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 71204KII53
Classification: ACTIM
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
tapentadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69865-265
Application NumberNDA200533
Product Classification
M
Marketing Category
C73594
G
Generic Name
tapentadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2018
FDA Product Classification
INGREDIENTS (12)
TAPENTADOL HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 71204KII53
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
tapentadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69865-245
Application NumberNDA200533
Product Classification
M
Marketing Category
C73594
G
Generic Name
tapentadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2018
FDA Product Classification
INGREDIENTS (12)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TAPENTADOL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 71204KII53
Classification: ACTIM
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
tapentadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69865-260
Application NumberNDA200533
Product Classification
M
Marketing Category
C73594
G
Generic Name
tapentadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2018
FDA Product Classification
INGREDIENTS (12)
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
TAPENTADOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 71204KII53
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
tapentadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69865-250
Application NumberNDA200533
Product Classification
M
Marketing Category
C73594
G
Generic Name
tapentadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2018
FDA Product Classification
INGREDIENTS (13)
TAPENTADOL HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 71204KII53
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT