NDC 63459-504

ACTIQ

Fentanyl Citrate

ACTIQ is a Oral; Transmucosal Lozenge in the Human Prescription Drug category. It is labeled and distributed by Cephalon, Llc. The primary component is Fentanyl Citrate.

• Product ID: 63459-504_28b6e3d8-c97c-4946-ae6e-63459ad749f1
• NDC: 63459-504
• Product Type: Human Prescription Drug
• Proprietary Name: ACTIQ
• Generic Name: Fentanyl Citrate
• Dosage Form: Lozenge
• Route of Administration: ORAL; TRANSMUCOSAL
• Marketing Start Date: 1999-01-20
• Marketing Category: NDA / NDA
• Application Number: NDA020747
• Labeler Name: Cephalon, LLC
• Substance Name: FENTANYL CITRATE
• Active Ingredient Strength: 400 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 63459-504-30

30 BLISTER PACK in 1 CARTON (63459-504-30) > 1 LOZENGE in 1 BLISTER PACK (63459-504-01)

• Marketing Start Date: 1999-01-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63459-504-01 [63459050401]

ACTIQ LOZENGE

• Marketing Category: NDA
• Application Number: NDA020747
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-01-20

NDC 63459-504-30 [63459050430]

ACTIQ LOZENGE

• Marketing Category: NDA
• Application Number: NDA020747
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-01-20

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL CITRATE	400 ug/1

OpenFDA Data

• SPL SET ID: 90b94524-f913-48b3-3771-7b2fcffd888a
• Manufacturer:
  • Cephalon, Inc.
• UNII:
  • MUN5LYG46H
• RxNorm Concept Unique ID - RxCUI:
  • 310293
  • 310297
  • 313993
  • 310295
  • 310294
  • 262219
  • 313992
  • 261106
  • 261107
  • 261110
  • 261108
  • 261109

Pharmacological Class

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

NDC Crossover Matching brand name "ACTIQ" or generic name "Fentanyl Citrate"

NDC	Brand Name	Generic Name
63459-502	ACTIQ	ACTIQ
63459-512	ACTIQ	ACTIQ
63459-516	ACTIQ	ACTIQ
63459-504	ACTIQ	ACTIQ
63459-506	ACTIQ	ACTIQ
63459-508	ACTIQ	ACTIQ
0093-7865	Fentanyl Citrate	Fentanyl Citrate
0093-7866	Fentanyl Citrate	Fentanyl Citrate
0093-7867	Fentanyl Citrate	Fentanyl Citrate
0093-7868	Fentanyl Citrate	Fentanyl Citrate
0093-7869	Fentanyl Citrate	Fentanyl Citrate
0093-7870	Fentanyl Citrate	Fentanyl Citrate
0406-9202	FENTANYL CITRATE	FENTANYL CITRATE