"50458-101-05" National Drug Code (NDC)

Duragesic 5 POUCH in 1 BOX (50458-101-05) > 1 PATCH in 1 POUCH
(Janssen Pharmaceuticals, Inc.)

NDC Code50458-101-05
Package Description5 POUCH in 1 BOX (50458-101-05) > 1 PATCH in 1 POUCH
Product NDC50458-101
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDuragesic
Proprietary Name Suffix(fentanyl System)
Non-Proprietary NameFentanyl
Dosage FormPATCH
UsageTRANSDERMAL
Start Marketing Date20181105
Marketing Category NameNDA
Application NumberNDA019813
ManufacturerJanssen Pharmaceuticals, Inc.
Substance NameFENTANYL
Strength12.5
Strength Unitug/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII

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