NDC 0093-3066

Icatibant

Icatibant

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

Product ID0093-3066_094ccc71-f1c2-49fa-a1d0-d01057107f8c
NDC0093-3066
Product TypeHuman Prescription Drug
Proprietary NameIcatibant
Generic NameIcatibant
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-07-15
Marketing CategoryANDA / ANDA
Application NumberANDA210118
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameICATIBANT ACETATE
Active Ingredient Strength10 mg/mL
Pharm ClassesBradykinin B2 Receptor Antagonist [EPC],Bradykinin B2 Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0093-3066-34

1 SYRINGE in 1 CARTON (0093-3066-34) > 3 mL in 1 SYRINGE
Marketing Start Date2019-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-3066-19 [00093306619]

Icatibant INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210118
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-15

NDC 0093-3066-34 [00093306634]

Icatibant INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210118
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-15

NDC 0093-3066-93 [00093306693]

Icatibant INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210118
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-15

Drug Details

Active Ingredients

IngredientStrength
ICATIBANT ACETATE10 mg/mL

Pharmacological Class

  • 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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