Nucynta

Manufacturing Establishments (2)

Janssen Pharmaceuticals, Inc.

Labeler

Collegium Pharmaceutical, Inc.

DUNS Number

080236951

Halo Pharmaceutical, Inc. d/b/a Cambrex

Labeler

Collegium Pharmaceutical, Inc.

DUNS Number

829609168

Products (3)

NDC Product Code

24510-100

Application Number

NDA022304

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

December 21, 2023

Ingredients

TapentadolActive

Code: 71204KII53Class: ACTIMQuantity: 100 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

Nucynta

NDC Product Code

24510-050

Application Number

NDA022304

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

December 21, 2023

Ingredients

TapentadolActive

Code: 71204KII53Class: ACTIMQuantity: 50 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

Nucynta

NDC Product Code

24510-075

Application Number

NDA022304

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

December 21, 2023

Ingredients

TapentadolActive

Code: 71204KII53Class: ACTIMQuantity: 75 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

AI-Powered Research

Premium Access

Nucynta

Manufacturing Establishments (2)

Products (3)

Nucynta

Nucynta

Nucynta