Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Quality Care Products, LLC
Quality Care Products, LLC
831276758
Products1
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
55700-792Application Number
NDA022304Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 18, 2019TALCInactive
Code: 7SEV7J4R1UClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TapentadolActive
Code: 71204KII53Class: ACTIMQuantity: 50 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT