Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Stat Rx USA
Stat Rx USA
786036330
Products2
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
16590-863Application Number
NDA022304Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 29, 2010lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
TapentadolActive
Code: 71204KII53Class: ACTIMQuantity: 50 mg in 1 1
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
polyvinyl alcoholInactive
Code: 532B59J990Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
aluminum oxideInactive
Code: LMI26O6933Class: IACT
NUCYNTA
Product Details
NDC Product Code
16590-289Application Number
NDA022304Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 29, 2010TapentadolActive
Code: 71204KII53Class: ACTIMQuantity: 100 mg in 1 1
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
aluminum oxideInactive
Code: LMI26O6933Class: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
polyvinyl alcoholInactive
Code: 532B59J990Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT