icatibant

Generic: icatibant

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icatibant
Generic Name icatibant
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

icatibant acetate 30 mg/3mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-351
Product ID 55150-351_ff0f66d4-bb7c-43a6-9475-f8d87f21abb4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213521
Listing Expiration 2026-12-31
Marketing Start 2023-08-14

Pharmacologic Class

Classes
bradykinin b2 receptor antagonist [epc] bradykinin b2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150351
Hyphenated Format 55150-351

Supplemental Identifiers

RxCUI
1148141
UPC
0355150351015
UNII
325O8467XK

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name icatibant (source: ndc)
Generic Name icatibant (source: ndc)
Application Number ANDA213521 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/3mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (55150-351-01) / 3 mL in 1 SYRINGE, GLASS
  • 3 CARTON in 1 CARTON (55150-351-03) / 1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

55150-351-01 1 SYRINGE, GLASS in 1 CARTON (55150-351-01) / 3 mL in 1 SYRINGE, GLASS 55150-351-03 3 CARTON in 1 CARTON (55150-351-03) / 1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS

Ingredients (1)

icatibant acetate (30 mg/3mL)

Linked Drug Pages (1)

Icatibant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "ff0f66d4-bb7c-43a6-9475-f8d87f21abb4", "openfda": {"upc": ["0355150351015"], "unii": ["325O8467XK"], "rxcui": ["1148141"], "spl_set_id": ["56d5047e-3f99-4100-af4f-388870986ced"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (55150-351-01)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "55150-351-01", "marketing_start_date": "20230814"}, {"sample": false, "description": "3 CARTON in 1 CARTON (55150-351-03)  / 1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "55150-351-03", "marketing_start_date": "20230814"}], "brand_name": "Icatibant", "product_id": "55150-351_ff0f66d4-bb7c-43a6-9475-f8d87f21abb4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bradykinin B2 Receptor Antagonist [EPC]", "Bradykinin B2 Receptor Antagonists [MoA]"], "product_ndc": "55150-351", "generic_name": "Icatibant", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icatibant", "active_ingredients": [{"name": "ICATIBANT ACETATE", "strength": "30 mg/3mL"}], "application_number": "ANDA213521", "marketing_category": "ANDA", "marketing_start_date": "20230814", "listing_expiration_date": "20261231"}