icatibant

Generic: icatibant

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icatibant
Generic Name icatibant
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

icatibant acetate 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-574
Product ID 63323-574_d1c9afa7-c4ac-4739-85f1-2ae82440210c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208317
Listing Expiration 2026-12-31
Marketing Start 2020-11-15

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 63323574
Hyphenated Format 63323-574

Supplemental Identifiers

RxCUI
1148141
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 ANDA208317 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (63323-574-86) / 3 mL in 1 SYRINGE (63323-574-01)
  • 3 CARTON in 1 BOX (63323-574-93) / 1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE
source: ndc

Packages (2)

63323-574-86 1 SYRINGE in 1 CARTON (63323-574-86) / 3 mL in 1 SYRINGE (63323-574-01) 63323-574-93 3 CARTON in 1 BOX (63323-574-93) / 1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE

Ingredients (1)

icatibant acetate (10 mg/mL)

Linked Drug Pages (1)

Icatibant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "d1c9afa7-c4ac-4739-85f1-2ae82440210c", "openfda": {"unii": ["325O8467XK"], "rxcui": ["1148141"], "spl_set_id": ["52c12c15-c00b-4efc-952d-1425c907706a"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (63323-574-86)  / 3 mL in 1 SYRINGE (63323-574-01)", "package_ndc": "63323-574-86", "marketing_start_date": "20201115"}, {"sample": false, "description": "3 CARTON in 1 BOX (63323-574-93)  / 1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE", "package_ndc": "63323-574-93", "marketing_start_date": "20201115"}], "brand_name": "Icatibant", "product_id": "63323-574_d1c9afa7-c4ac-4739-85f1-2ae82440210c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bradykinin B2 Receptor Antagonist [EPC]", "Bradykinin B2 Receptor Antagonists [MoA]"], "product_ndc": "63323-574", "generic_name": "Icatibant", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icatibant", "active_ingredients": [{"name": "ICATIBANT ACETATE", "strength": "10 mg/mL"}], "application_number": "ANDA208317", "marketing_category": "ANDA", "marketing_start_date": "20201115", "listing_expiration_date": "20261231"}