Nucynta
These 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: 2008
Approved
Approval ID
4a6953cd-9d64-4443-b7db-5aef2c81324d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
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 Code54868-6039
Application NumberNDA022304
Product Classification
M
Marketing Category
C73594
G
Generic Name
tapentadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2011
FDA Product Classification
INGREDIENTS (11)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TAPENTADOL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 71204KII53
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
tapentadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6002
Application NumberNDA022304
Product Classification
M
Marketing Category
C73594
G
Generic Name
tapentadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2011
FDA Product Classification
INGREDIENTS (11)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TAPENTADOL HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 71204KII53
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
tapentadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5979
Application NumberNDA022304
Product Classification
M
Marketing Category
C73594
G
Generic Name
tapentadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2011
FDA Product Classification
INGREDIENTS (11)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TAPENTADOL HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 71204KII53
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT