Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
STAT RX USA LLC
STAT RX USA LLC
786036330
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
16590-889Application Number
NDA022304Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 9, 2010POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TapentadolActive
Code: 71204KII53Class: ACTIBQuantity: 75 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT