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 ID51862-634_946972d3-b88b-4b7a-9d52-5010b846b6cb
NDC51862-634
Product TypeHuman Prescription Drug
Proprietary NameFentanyl Buccal
Generic NameFentanyl Citrate
Dosage FormTablet
Route of AdministrationBUCCAL; SUBLINGUAL
Marketing Start Date2019-06-14
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021947
Labeler NameMayne Pharma
Substance NameFENTANYL CITRATE
Active Ingredient Strength100 ug/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

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 Date2019-06-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51862-634-28 [51862063428]

Fentanyl Buccal TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA021947
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-14

NDC 51862-634-01 [51862063401]

Fentanyl Buccal TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA021947
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-14

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE100 ug/1

OpenFDA Data

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

Pharmacological Class

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

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

NDCBrand NameGeneric Name
51862-637Fentanyl BuccalFentanyl Buccal
51862-636Fentanyl BuccalFentanyl Buccal
51862-638Fentanyl BuccalFentanyl Buccal
51862-634Fentanyl BuccalFentanyl Buccal
51862-635Fentanyl BuccalFentanyl Buccal
0093-7865Fentanyl CitrateFentanyl Citrate
0093-7866Fentanyl CitrateFentanyl Citrate
0093-7867Fentanyl CitrateFentanyl Citrate
0093-7868Fentanyl CitrateFentanyl Citrate
0093-7869Fentanyl CitrateFentanyl Citrate
0093-7870Fentanyl CitrateFentanyl Citrate
0406-9202FENTANYL CITRATEFENTANYL CITRATE

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