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 ID63459-504_28b6e3d8-c97c-4946-ae6e-63459ad749f1
NDC63459-504
Product TypeHuman Prescription Drug
Proprietary NameACTIQ
Generic NameFentanyl Citrate
Dosage FormLozenge
Route of AdministrationORAL; TRANSMUCOSAL
Marketing Start Date1999-01-20
Marketing CategoryNDA / NDA
Application NumberNDA020747
Labeler NameCephalon, LLC
Substance NameFENTANYL CITRATE
Active Ingredient Strength400 ug/1
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

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 Date1999-01-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63459-504-01 [63459050401]

ACTIQ LOZENGE
Marketing CategoryNDA
Application NumberNDA020747
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-01-20

NDC 63459-504-30 [63459050430]

ACTIQ LOZENGE
Marketing CategoryNDA
Application NumberNDA020747
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-01-20

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE400 ug/1

OpenFDA Data

SPL SET ID:90b94524-f913-48b3-3771-7b2fcffd888a
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    63459-502ACTIQACTIQ
    63459-512ACTIQACTIQ
    63459-516ACTIQACTIQ
    63459-504ACTIQACTIQ
    63459-506ACTIQACTIQ
    63459-508ACTIQACTIQ
    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

    Trademark Results [ACTIQ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ACTIQ
    ACTIQ
    90323731 not registered Live/Pending
    NewCompliance B.V.
    2020-11-17
    ACTIQ
    ACTIQ
    75096187 2162569 Live/Registered
    ANESTA, LLC
    1996-04-29

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