NDC 57881-332

Abstral

Fentanyl Citrate

Abstral is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Galena Biopharma, Inc.. The primary component is Fentanyl Citrate.

Product ID57881-332_621fd88b-b921-47a2-94bd-a778d6005353
NDC57881-332
Product TypeHuman Prescription Drug
Proprietary NameAbstral
Generic NameFentanyl Citrate
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2013-08-08
Marketing CategoryNDA / NDA
Application NumberNDA022510
Labeler NameGalena Biopharma, Inc.
Substance NameFENTANYL CITRATE
Active Ingredient Strength200 ug/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 57881-332-32

8 BLISTER PACK in 1 CARTON (57881-332-32) > 4 TABLET in 1 BLISTER PACK (57881-332-04)
Marketing Start Date2013-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57881-332-04 [57881033204]

Abstral TABLET
Marketing CategoryNDA
Application NumberNDA022510
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-08

NDC 57881-332-32 [57881033232]

Abstral TABLET
Marketing CategoryNDA
Application NumberNDA022510
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE200 ug/1

OpenFDA Data

SPL SET ID:f969e2bc-6297-4e29-89d3-a3685a2c7c6b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1053652
  • 1053651
  • 1053658
  • 1053657
  • 1053655
  • 1053654
  • 1053661
  • 1053663
  • 1053660
  • 1053647
  • 1053666
  • 1053664
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    42747-226AbstralAbstral
    42747-222AbstralAbstral
    42747-224AbstralAbstral
    42747-221AbstralAbstral
    42747-223AbstralAbstral
    42747-228AbstralAbstral
    57881-338AbstralAbstral
    57881-336AbstralAbstral
    57881-332AbstralAbstral
    57881-333AbstralAbstral
    57881-334AbstralAbstral
    57881-331AbstralAbstral
    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 [Abstral]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ABSTRAL
    ABSTRAL
    77117021 3563010 Live/Registered
    SENTYNL THERAPEUTICS, INC.
    2007-02-27

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.