NDC 54092-702

Firazyr

Icatibant Acetate

Firazyr is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Shire Us Manufacturing Inc.. The primary component is Icatibant Acetate.

Product ID54092-702_120b58c8-8b37-4932-a1ec-8cc06daa3819
NDC54092-702
Product TypeHuman Prescription Drug
Proprietary NameFirazyr
Generic NameIcatibant Acetate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2011-08-25
Marketing CategoryNDA / NDA
Application NumberNDA022150
Labeler NameShire US Manufacturing Inc.
Substance NameICATIBANT ACETATE
Active Ingredient Strength30 mg/3mL
Pharm ClassesBradykinin B2 Receptor Antagonist [EPC],Bradykinin B2 Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 54092-702-01

1 SYRINGE, GLASS in 1 CARTON (54092-702-01) > 3 mL in 1 SYRINGE, GLASS
Marketing Start Date2011-08-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-702-02 [54092070202]

Firazyr INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA022150
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-08-25

NDC 54092-702-03 [54092070203]

Firazyr INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA022150
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-08-25

NDC 54092-702-01 [54092070201]

Firazyr INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA022150
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-25

Drug Details

Active Ingredients

IngredientStrength
ICATIBANT ACETATE30 mg/3mL

OpenFDA Data

SPL SET ID:ed6657ca-ab68-477a-9968-e12dc928b540
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1148141
  • 1148145
  • Pharmacological Class

    • Bradykinin B2 Receptor Antagonist [EPC]
    • Bradykinin B2 Receptor Antagonists [MoA]

    NDC Crossover Matching brand name "Firazyr" or generic name "Icatibant Acetate"

    NDCBrand NameGeneric Name
    54092-135Firazyricatibant acetate
    54092-702Firazyricatibant acetate
    60505-6214ICATIBANTicatibant acetate
    68462-828Icatibanticatibant acetate

    Trademark Results [Firazyr]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FIRAZYR
    FIRAZYR
    78876453 3329286 Live/Registered
    Shire Orphan Therapies GmbH
    2006-05-04

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