NDC 68462-828

Icatibant

Icatibant Acetate

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

Product ID68462-828_8d6e2f8a-884d-48eb-b95f-f74d5ddd6c65
NDC68462-828
Product TypeHuman Prescription Drug
Proprietary NameIcatibant
Generic NameIcatibant Acetate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2021-05-21
Marketing CategoryANDA /
Application NumberANDA213222
Labeler NameGLENMARK PHARMACEUTICALS INC., USA
Substance NameICATIBANT ACETATE
Active Ingredient Strength30 mg/3mL
Pharm ClassesBradykinin B2 Receptor Antagonist [EPC], Bradykinin B2 Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68462-828-15

1 SYRINGE, GLASS in 1 CARTON (68462-828-15) > 3 mL in 1 SYRINGE, GLASS
Marketing Start Date2021-05-21
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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