"50458-863-01" National Drug Code (NDC)

Nucynta 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-863-01)
(Janssen Pharmaceuticals, Inc.)

NDC Code50458-863-01
Package Description60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-863-01)
Product NDC50458-863
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNucynta
Proprietary Name SuffixEr
Non-Proprietary NameTapentadol Hydrochloride
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20110825
End Marketing Date20200331
Marketing Category NameNDA
Application NumberNDA200533
ManufacturerJanssen Pharmaceuticals, Inc.
Substance NameTAPENTADOL HYDROCHLORIDE
Strength200
Strength Unitmg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII

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