NDC 42358-200

Abstral fentanyl

Fentanyl Citrate

Abstral fentanyl is a Sublingual Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Sentynl Therapeutics, Inc.. The primary component is Fentanyl Citrate.

Product ID42358-200_463c068d-9e51-43c7-8d01-116947effb42
NDC42358-200
Product TypeHuman Prescription Drug
Proprietary NameAbstral fentanyl
Generic NameFentanyl Citrate
Dosage FormTablet, Orally Disintegrating
Route of AdministrationSUBLINGUAL
Marketing Start Date2016-10-01
Marketing CategoryNDA / NDA
Application NumberNDA022510
Labeler NameSentynl Therapeutics, 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 42358-200-32

8 BLISTER PACK in 1 CARTON (42358-200-32) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date2016-10-01
Marketing End Date2022-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42358-200-32 [42358020032]

Abstral fentanyl TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA022510
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-01
Marketing End Date2022-04-30

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE200 ug/1

OpenFDA Data

SPL SET ID:e60f00e9-2cf4-4c20-b570-1c2ea426c8c7
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 fentanyl" or generic name "Fentanyl Citrate"

    NDCBrand NameGeneric Name
    42358-300Abstral fentanylAbstral fentanyl
    42358-100Abstral fentanylAbstral fentanyl
    42358-400Abstral fentanylAbstral fentanyl
    42358-800Abstral fentanylAbstral fentanyl
    42358-200Abstral fentanylAbstral fentanyl
    42358-600Abstral fentanylAbstral fentanyl
    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

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