NDC 69097-664

ICATIBANT

Icatibant

ICATIBANT is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Icatibant Acetate.

Product ID69097-664_38971837-750d-4016-bc05-618d00dacf0d
NDC69097-664
Product TypeHuman Prescription Drug
Proprietary NameICATIBANT
Generic NameIcatibant
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2020-07-13
Marketing CategoryANDA / ANDA
Application NumberANDA212446
Labeler NameCipla USA 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 Through2023-12-31

Packaging

NDC 69097-664-34

1 SYRINGE, GLASS in 1 CARTON (69097-664-34) > 3 mL in 1 SYRINGE, GLASS
Marketing Start Date2020-07-13
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.