50458-092 : Duragesic 50 ug/H Transdermal Patch


NDC50458-092
Labeler: Janssen Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Duragesic
Dosage Form: Transdermal Patch
Application #: NDA019813
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 50458-092-05: 5 POUCH IN 1 BOX (50458‑092‑05) > 1 PATCH IN 1 POUCH > 72 H IN 1 PATCH

Active Ingredients:

  • Fentanyl

Dosage Strength:

  • 50 ug/h

Pharmaceutical Classes:

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 50458-090 Duragesic 12.5 ug/H Transdermal Patch by Janssen Pharmaceuticals, Inc.
  • 50458-091 Duragesic 25 ug/H Transdermal Patch by Janssen Pharmaceuticals, Inc.
  • 50458-093 Duragesic 75 ug/H Transdermal Patch by Janssen Pharmaceuticals, Inc.
  • 50458-094 Duragesic 100 ug/H Transdermal Patch by Janssen Pharmaceuticals, Inc.

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