NDC 0378-9119

FENTANYL

Fentanyl

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

• Product ID: 0378-9119_5cbb788c-026f-496d-b801-f63f6b53a99b
• NDC: 0378-9119
• Product Type: Human Prescription Drug
• Proprietary Name: FENTANYL
• Generic Name: Fentanyl
• Dosage Form: Patch
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2007-01-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076258
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: FENTANYL
• Active Ingredient Strength: 12 ug/h
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0378-9119-98

5 POUCH in 1 CARTON (0378-9119-98) > 1 PATCH in 1 POUCH (0378-9119-16) > 72 h in 1 PATCH

• Marketing Start Date: 2007-01-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-9119-98 [00378911998]

FENTANYL PATCH

• Marketing Category: ANDA
• Application Number: ANDA076258
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-01-23

NDC 0378-9119-16 [00378911916]

FENTANYL PATCH

• Marketing Category: ANDA
• Application Number: ANDA076258
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-01-23

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL	12 ug/h

OpenFDA Data

• SPL SET ID: 2a2238e9-4b5d-c56d-8663-dd354ff9ae0c
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • UF599785JZ
• RxNorm Concept Unique ID - RxCUI:
  • 1603501
  • 197696
  • 245136
  • 245135
  • 245134
  • 1603498
  • 577057
  • 1603495

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
68258-3023	Fentanyl	Fentanyl
68258-3040	Fentanyl	Fentanyl
68258-3024	Fentanyl	Fentanyl
68258-3025	Fentanyl	Fentanyl
71335-0376	FENTANYL	FENTANYL
71335-0649	Fentanyl	Fentanyl
71335-0556	Fentanyl	Fentanyl
71335-0604	Fentanyl	Fentanyl
35356-633	FENTANYL	FENTANYL
35356-635	Fentanyl	Fentanyl
35356-062	Fentanyl	Fentanyl
35356-632	FENTANYL	FENTANYL
35356-634	FENTANYL	FENTANYL
49884-763	Fentanyl	Fentanyl
49884-762	Fentanyl	Fentanyl
49884-764	Fentanyl	Fentanyl
49884-761	Fentanyl	Fentanyl
49999-834	Fentanyl	Fentanyl
49999-832	Fentanyl	Fentanyl
49999-833	Fentanyl	Fentanyl
49999-831	Fentanyl	Fentanyl
51862-317	Fentanyl	Fentanyl
51862-314	Fentanyl	Fentanyl
51862-316	Fentanyl	Fentanyl
51862-315	Fentanyl	Fentanyl
52959-585	Fentanyl	Fentanyl
52959-658	Fentanyl	Fentanyl
55700-402	FENTANYL	FENTANYL
60505-7081	FENTANYL	FENTANYL
60505-7086	FENTANYL	FENTANYL
60505-7082	FENTANYL	FENTANYL
60505-7009	FENTANYL	FENTANYL
60505-7014	FENTANYL	FENTANYL