Nucynta
These highlights do not include all the information needed to use NUCYNTA TABLETS safely and effectively. See full prescribing information for NUCYNTA TABLETS. NUCYNTA (tapentadol) tablets for oral use C-II Initial U.S. Approval: 2008
Approved
Approval ID
80938c30-9fe3-4c7d-9d9c-5476638cfb2d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
Collegium Pharmaceutical, Inc.
DUNS: 032531241
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 Code24510-100
Application NumberNDA022304
Product Classification
M
Marketing Category
C73594
G
Generic Name
tapentadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (11)
TAPENTADOL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 71204KII53
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
tapentadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24510-050
Application NumberNDA022304
Product Classification
M
Marketing Category
C73594
G
Generic Name
tapentadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (11)
TAPENTADOL HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 71204KII53
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
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 Code24510-075
Application NumberNDA022304
Product Classification
M
Marketing Category
C73594
G
Generic Name
tapentadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (11)
TAPENTADOL HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 71204KII53
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT