NDC 50458-094

DURAGESIC

Fentanyl

DURAGESIC is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Fentanyl.

• Product ID: 50458-094_4510e337-3d1f-4eab-907e-85e95dc7d5a0
• NDC: 50458-094
• Product Type: Human Prescription Drug
• Proprietary Name: DURAGESIC
• Generic Name: Fentanyl
• Dosage Form: Patch
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 1990-08-07
• Marketing End Date: 2020-03-31
• Marketing Category: NDA / NDA
• Application Number: NDA019813
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: FENTANYL
• Active Ingredient Strength: 100 ug/h
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N

Packaging

NDC 50458-094-05

5 POUCH in 1 BOX (50458-094-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH

• Marketing Start Date: 1990-08-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-094-05 [50458009405]

DURAGESIC PATCH

• Marketing Category: NDA
• Application Number: NDA019813
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1990-08-07
• Marketing End Date: 2020-03-31

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL	100 ug/h

OpenFDA Data

• SPL SET ID: d7aade83-9e69-4cd5-8dab-dbf1d7b89bb4
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • UF599785JZ
• RxNorm Concept Unique ID - RxCUI:
  • 261184
  • 261185
  • 197696
  • 583490
  • 245136
  • 245135
  • 245134
  • 577057
  • 262071
  • 261186

Pharmacological Class

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

Medicade Reported Pricing

50458094301 INVOKAMET XR 150-1,000 MG TAB

Pricing Unit: EA | Drug Type:

50458094201 INVOKAMET XR 150-500 MG TABLET

Pricing Unit: EA | Drug Type:

50458094101 INVOKAMET XR 50-1,000 MG TAB

Pricing Unit: EA | Drug Type:

50458094001 INVOKAMET XR 50-500 MG TABLET

Pricing Unit: EA | Drug Type:

50458009405 DURAGESIC 100 MCG/HR PATCH

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "DURAGESIC" or generic name "Fentanyl"

NDC	Brand Name	Generic Name
50458-090	DURAGESIC	DURAGESIC
50458-093	DURAGESIC	DURAGESIC
50458-094	DURAGESIC	DURAGESIC
50458-091	DURAGESIC	DURAGESIC
50458-092	DURAGESIC	DURAGESIC
0378-9119	FENTANYL	FENTANYL
0378-9121	FENTANYL	FENTANYL
0378-9122	FENTANYL	FENTANYL
0378-9123	FENTANYL	FENTANYL
0378-9124	FENTANYL	FENTANYL
0378-9125	FENTANYL	FENTANYL
0378-9126	FENTANYL	FENTANYL
0378-9127	FENTANYL	FENTANYL
0591-3198	Fentanyl	Fentanyl
0591-3212	Fentanyl	Fentanyl
0591-3213	Fentanyl	Fentanyl
0591-3214	Fentanyl	Fentanyl
0781-7240	Fentanyl	Fentanyl
0781-7241	Fentanyl	Fentanyl
0781-7242	Fentanyl	Fentanyl
0781-7243	Fentanyl	Fentanyl
0781-7244	Fentanyl	Fentanyl
20482-001	SUBSYS	fentanyl
20482-002	SUBSYS	fentanyl