firazyr

Generic: icatibant acetate

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name firazyr
Generic Name icatibant acetate
Labeler takeda pharmaceuticals america, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

icatibant acetate 30 mg/3mL

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 54092-702
Product ID 54092-702_19b83a10-9f38-4d0d-ae46-0f5b28168873
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022150
Listing Expiration 2026-12-31
Marketing Start 2011-08-25

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 54092702
Hyphenated Format 54092-702

Supplemental Identifiers

RxCUI
1148141 1148145
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 firazyr (source: ndc)
Generic Name icatibant acetate (source: ndc)
Application Number NDA022150 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/3mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (54092-702-01) / 3 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 CARTON (54092-702-02) / 3 mL in 1 SYRINGE, GLASS
  • 3 SYRINGE, GLASS in 1 CARTON (54092-702-03) / 3 mL in 1 SYRINGE, GLASS
source: ndc

Packages (3)

54092-702-01 1 SYRINGE, GLASS in 1 CARTON (54092-702-01) / 3 mL in 1 SYRINGE, GLASS 54092-702-02 1 SYRINGE, GLASS in 1 CARTON (54092-702-02) / 3 mL in 1 SYRINGE, GLASS 54092-702-03 3 SYRINGE, GLASS in 1 CARTON (54092-702-03) / 3 mL in 1 SYRINGE, GLASS

Ingredients (1)

icatibant acetate (30 mg/3mL)

Linked Drug Pages (1)

Firazyr ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "19b83a10-9f38-4d0d-ae46-0f5b28168873", "openfda": {"unii": ["325O8467XK"], "rxcui": ["1148141", "1148145"], "spl_set_id": ["ed6657ca-ab68-477a-9968-e12dc928b540"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (54092-702-01)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "54092-702-01", "marketing_start_date": "20110825"}, {"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (54092-702-02)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "54092-702-02", "marketing_start_date": "20110825"}, {"sample": false, "description": "3 SYRINGE, GLASS in 1 CARTON (54092-702-03)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "54092-702-03", "marketing_start_date": "20110825"}], "brand_name": "Firazyr", "product_id": "54092-702_19b83a10-9f38-4d0d-ae46-0f5b28168873", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bradykinin B2 Receptor Antagonist [EPC]", "Bradykinin B2 Receptor Antagonists [MoA]"], "product_ndc": "54092-702", "generic_name": "icatibant acetate", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Firazyr", "active_ingredients": [{"name": "ICATIBANT ACETATE", "strength": "30 mg/3mL"}], "application_number": "NDA022150", "marketing_category": "NDA", "marketing_start_date": "20110825", "listing_expiration_date": "20261231"}