NDC 63323-574

Icatibant

Icatibant

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

Product ID63323-574_a9f19a4a-ee09-4185-b8ea-27ac98b92b47
NDC63323-574
Product TypeHuman Prescription Drug
Proprietary NameIcatibant
Generic NameIcatibant
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2020-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA208317
Labeler NameFresenius Kabi USA, LLC
Substance NameICATIBANT ACETATE
Active Ingredient Strength10 mg/mL
Pharm ClassesBradykinin B2 Receptor Antagonist [EPC],Bradykinin B2 Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63323-574-86

1 SYRINGE in 1 CARTON (63323-574-86) > 3 mL in 1 SYRINGE (63323-574-01)
Marketing Start Date2020-11-15
NDC Exclude FlagN
Sample Package?N

Drug Details

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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