Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nucynta
Product Details
NDC Product Code
54868-6039Application Number
NDA022304Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 9, 2011TALCInactive
Code: 7SEV7J4R1UClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
TapentadolActive
Code: 71204KII53Class: ACTIBQuantity: 100 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
Nucynta
Product Details
NDC Product Code
54868-6002Application Number
NDA022304Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 9, 2011POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TapentadolActive
Code: 71204KII53Class: ACTIBQuantity: 75 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
Nucynta
Product Details
NDC Product Code
54868-5979Application Number
NDA022304Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 9, 2011TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TapentadolActive
Code: 71204KII53Class: ACTIBQuantity: 50 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT