Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Janssen Pharmaceuticals, Inc.
Depo NF Sub, LLC
080236951
Janssen Ortho, LLC
Depo NF Sub, LLC
805887986
Products5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nucynta ER
Product Details
NDC Product Code
69865-240Application Number
NDA200533Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 24, 2018TapentadolActive
Code: 71204KII53Class: ACTIMQuantity: 50 mg in 1 1
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
Nucynta ER
Product Details
NDC Product Code
69865-265Application Number
NDA200533Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 24, 2018TapentadolActive
Code: 71204KII53Class: ACTIMQuantity: 250 mg in 1 1
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
Nucynta ER
Product Details
NDC Product Code
69865-245Application Number
NDA200533Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 24, 2018POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TapentadolActive
Code: 71204KII53Class: ACTIMQuantity: 100 mg in 1 1
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
Nucynta ER
Product Details
NDC Product Code
69865-260Application Number
NDA200533Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 24, 2018POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
TapentadolActive
Code: 71204KII53Class: ACTIMQuantity: 200 mg in 1 1
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
Nucynta ER
Product Details
NDC Product Code
69865-250Application Number
NDA200533Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 24, 2018TapentadolActive
Code: 71204KII53Class: ACTIMQuantity: 150 mg in 1 1
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT