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 ID63459-541_37976b20-73f5-4be6-87fe-a8a7e53d4cb4
NDC63459-541
Product TypeHuman Prescription Drug
Proprietary NameFENTORA
Generic NameFentanyl
Dosage FormTablet
Route of AdministrationBUCCAL; SUBLINGUAL
Marketing Start Date2006-10-02
Marketing CategoryNDA / NDA
Application NumberNDA021947
Labeler NameCephalon, LLC
Substance NameFENTANYL CITRATE
Active Ingredient Strength100 ug/1
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

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 Date2006-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63459-541-28 [63459054128]

FENTORA TABLET
Marketing CategoryNDA
Application NumberNDA021947
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-02

NDC 63459-541-04 [63459054104]

FENTORA TABLET
Marketing CategoryNDA
Application NumberNDA021947
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-02

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE100 ug/1

OpenFDA Data

SPL SET ID:8f549d95-985b-f783-1ebb-ef57bd2ecb05
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    63459-548FENTORAFENTORA
    63459-544FENTORAFENTORA
    63459-546FENTORAFENTORA
    63459-542FENTORAFENTORA
    63459-541FENTORAFENTORA
    0378-9119FENTANYLFENTANYL
    0378-9121FENTANYLFENTANYL
    0378-9122FENTANYLFENTANYL
    0378-9123FENTANYLFENTANYL
    0378-9124FENTANYLFENTANYL
    0378-9125FENTANYLFENTANYL
    0378-9126FENTANYLFENTANYL
    0378-9127FENTANYLFENTANYL
    0591-3198FentanylFentanyl
    0591-3212FentanylFentanyl
    0591-3213FentanylFentanyl
    0591-3214FentanylFentanyl
    0781-7240FentanylFentanyl
    0781-7241FentanylFentanyl
    0781-7242FentanylFentanyl
    0781-7243FentanylFentanyl
    0781-7244FentanylFentanyl
    20482-001SUBSYSfentanyl
    20482-002SUBSYSfentanyl

    Trademark Results [FENTORA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FENTORA
    FENTORA
    78645211 3214090 Live/Registered
    Cima Labs, Inc.
    2005-06-07
    FENTORA
    FENTORA
    77817728 3777475 Live/Registered
    CIMA LABS INC.
    2009-09-01

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