NDC 50458-101

DURAGESIC (fentanyl system)

Fentanyl

DURAGESIC (fentanyl system) 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: 50458-101_05923670-9dd6-4a7c-91b6-1483b3db3c29
• NDC: 50458-101
• Product Type: Human Prescription Drug
• Proprietary Name: DURAGESIC (fentanyl system)
• Generic Name: Fentanyl
• Dosage Form: Patch
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2018-11-05
• Marketing Category: NDA / NDA
• Application Number: NDA019813
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: FENTANYL
• Active Ingredient Strength: 13 ug/1
• Pharm Classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50458-101-05

5 POUCH in 1 BOX (50458-101-05) > 1 PATCH in 1 POUCH

• Marketing Start Date: 2018-11-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-101-05 [50458010105]

DURAGESIC (fentanyl system) PATCH

• Marketing Category: NDA
• Application Number: NDA019813
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-15

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL	12.5 ug/1

OpenFDA Data

• SPL SET ID: 4c3a6171-19e4-40c2-83f3-fb54d4736e4b
• 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]

NDC Crossover Matching brand name "DURAGESIC (fentanyl system)" or generic name "Fentanyl"

NDC	Brand Name	Generic Name
50458-101	DURAGESIC (fentanyl system)	DURAGESIC (fentanyl system)
50458-106	DURAGESIC (fentanyl system)	DURAGESIC (fentanyl system)
50458-102	DURAGESIC (fentanyl system)	DURAGESIC (fentanyl system)
50458-104	DURAGESIC (fentanyl system)	DURAGESIC (fentanyl system)
50458-105	DURAGESIC (fentanyl system)	DURAGESIC (fentanyl system)
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