NDC 63459-541

FENTORA

Fentanyl

FENTORA is a Buccal; Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Cephalon, Llc. The primary component is Fentanyl Citrate.

• Product ID: 63459-541_37976b20-73f5-4be6-87fe-a8a7e53d4cb4
• NDC: 63459-541
• Product Type: Human Prescription Drug
• Proprietary Name: FENTORA
• Generic Name: Fentanyl
• Dosage Form: Tablet
• Route of Administration: BUCCAL; SUBLINGUAL
• Marketing Start Date: 2006-10-02
• Marketing Category: NDA / NDA
• Application Number: NDA021947
• Labeler Name: Cephalon, LLC
• Substance Name: FENTANYL CITRATE
• Active Ingredient Strength: 100 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 63459-541-28

28 BLISTER PACK in 1 CARTON (63459-541-28) > 1 TABLET in 1 BLISTER PACK (63459-541-04)

• Marketing Start Date: 2006-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63459-541-28 [63459054128]

FENTORA TABLET

• Marketing Category: NDA
• Application Number: NDA021947
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-10-02

NDC 63459-541-04 [63459054104]

FENTORA TABLET

• Marketing Category: NDA
• Application Number: NDA021947
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-10-02

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL CITRATE	100 ug/1

OpenFDA Data

• SPL SET ID: 8f549d95-985b-f783-1ebb-ef57bd2ecb05
• Manufacturer:
  • Cephalon, Inc.
• UNII:
  • MUN5LYG46H
• RxNorm Concept Unique ID - RxCUI:
  • 668622
  • 668630
  • 668626
  • 668624
  • 668628
  • 668367
  • 668366
  • 668365
  • 668364
  • 668363

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
63459-548	FENTORA	FENTORA
63459-544	FENTORA	FENTORA
63459-546	FENTORA	FENTORA
63459-542	FENTORA	FENTORA
63459-541	FENTORA	FENTORA
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