NDC 54092-135

Icatibant

Icatibant

Icatibant is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Icatibant Acetate.

Product ID54092-135_2a050e37-c5c7-457b-95d1-55988a5d1fc5
NDC54092-135
Product TypeHuman Prescription Drug
Proprietary NameIcatibant
Generic NameIcatibant
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-07-30
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022150
Labeler NameTakeda Pharmaceuticals America, 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 Through2022-12-31

Packaging

NDC 54092-135-01

1 SYRINGE, GLASS in 1 CARTON (54092-135-01) > 3 mL in 1 SYRINGE, GLASS
Marketing Start Date2019-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-135-02 [54092013502]

Firazyr INJECTION, SOLUTION
Marketing CategoryNDA authorized generic
Application NumberNDA022150
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-30

NDC 54092-135-01 [54092013501]

Firazyr INJECTION, SOLUTION
Marketing CategoryNDA authorized generic
Application NumberNDA022150
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-30

Drug Details

Active Ingredients

IngredientStrength
ICATIBANT ACETATE30 mg/3mL

OpenFDA Data

SPL SET ID:b1d59c74-3282-4f22-b5cb-ba5c33cf2bd1
Manufacturer
UNII

Pharmacological Class

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

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

NDCBrand NameGeneric Name
0093-3066IcatibantIcatibant
24201-207Icatibanticatibant
54092-135IcatibantIcatibant
60505-6214ICATIBANTicatibant acetate
63323-574IcatibantIcatibant
68462-828Icatibanticatibant acetate
69097-664ICATIBANTICATIBANT
71225-114IcatibantIcatibant
70709-013SAJAZIRICATIBANT

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