NDC 51862-634

Fentanyl Buccal

Fentanyl Citrate

Fentanyl Buccal is a Buccal; Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Mayne Pharma. The primary component is Fentanyl Citrate.

• Product ID: 51862-634_946972d3-b88b-4b7a-9d52-5010b846b6cb
• NDC: 51862-634
• Product Type: Human Prescription Drug
• Proprietary Name: Fentanyl Buccal
• Generic Name: Fentanyl Citrate
• Dosage Form: Tablet
• Route of Administration: BUCCAL; SUBLINGUAL
• Marketing Start Date: 2019-06-14
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA021947
• Labeler Name: Mayne Pharma
• 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: 2022-12-31

Packaging

NDC 51862-634-28

28 BLISTER PACK in 1 CARTON (51862-634-28) > 1 TABLET in 1 BLISTER PACK (51862-634-01)

• Marketing Start Date: 2019-06-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51862-634-28 [51862063428]

Fentanyl Buccal TABLET

• Marketing Category: NDA authorized generic
• Application Number: NDA021947
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-14

NDC 51862-634-01 [51862063401]

Fentanyl Buccal TABLET

• Marketing Category: NDA authorized generic
• Application Number: NDA021947
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-14

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL CITRATE	100 ug/1

OpenFDA Data

• SPL SET ID: 918d0e2a-3af3-46e8-ad06-528263e03ba0
• Manufacturer:
  • Mayne Pharma
• UNII:
  • MUN5LYG46H

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
51862-637	Fentanyl Buccal	Fentanyl Buccal
51862-636	Fentanyl Buccal	Fentanyl Buccal
51862-638	Fentanyl Buccal	Fentanyl Buccal
51862-634	Fentanyl Buccal	Fentanyl Buccal
51862-635	Fentanyl Buccal	Fentanyl Buccal
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