NDC 60505-6214

ICATIBANT

Icatibant Acetate

ICATIBANT is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Icatibant Acetate.

Product ID60505-6214_626483ed-d5c0-49d9-b8f8-3fd1920118ca
NDC60505-6214
Product TypeHuman Prescription Drug
Proprietary NameICATIBANT
Generic NameIcatibant Acetate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2020-12-18
Marketing CategoryANDA / ANDA
Application NumberANDA212081
Labeler NameApotex Corp.
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 60505-6214-1

1 SYRINGE, GLASS in 1 CARTON (60505-6214-1) > 3 mL in 1 SYRINGE, GLASS
Marketing Start Date2020-12-18
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0093-3066IcatibantIcatibant
24201-207Icatibanticatibant
54092-135IcatibantIcatibant
60505-6214ICATIBANTicatibant acetate
63323-574IcatibantIcatibant
68462-828Icatibanticatibant acetate
69097-664ICATIBANTICATIBANT
71225-114IcatibantIcatibant
54092-702Firazyricatibant acetate
70709-013SAJAZIRICATIBANT

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