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United States · US · US:54092-702_19b83a10-9f38-4d0d-ae46-0f5b28168873
Firazyr
In shortageOrange BookUNIISPLATC B06AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeB06AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1154092702011 SYRINGE, GLASS in 1 CARTON (54092-702-01) / 3 mL in 1 SYRINGE, GLASS
- ndc1154092702021 SYRINGE, GLASS in 1 CARTON (54092-702-02) / 3 mL in 1 SYRINGE, GLASS
- ndc1154092702033 SYRINGE, GLASS in 1 CARTON (54092-702-03) / 3 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
325O8467XK
ICATIBANT ACETATE
RxCUI 1294605
Orange Book
N022150
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Icatibant Acetate Injection
Raw payload (JSON)
{
"unii": {
"unii": "325O8467XK",
"rxcui": "1294605",
"inchikey": "HKMZRZUEADSZDQ-DZJWSCHMSA-N",
"display_name": "ICATIBANT ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"ed6657ca-ab68-477a-9968-e12dc928b540": {
"match": "brand_token",
"title": "FIRAZYR (ICATIBANT ACETATE) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
"spl_version": "19",
"published_date": "2025-07-17"
}
},
"productid": "54092-702_19b83a10-9f38-4d0d-ae46-0f5b28168873",
"productndc": "54092-702",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "022150",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "EQ 30MG BASE/3ML (EQ 10MG BASE/ML)",
"product_no": "001",
"approval_date": "Aug 25, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ICATIBANT ACETATE",
"shortage_reason": "Icatibant Acetate Injection",
"shortage_status": "current",
"proprietary_name": "Firazyr",
"active_ingred_unit": "mg/3mL",
"application_number": "NDA022150",
"marketing_category": "NDA",
"nonproprietary_name": "icatibant acetate",
"start_marketing_date": "20110825",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code B06AC02.
- FIFirazyrParanova Oy
- FIFirazyrTakeda Pharmaceuticals International AG Ireland Branch
- NOFirazyrTakeda Pharmaceuticals International AG Ireland Branch
- 🇨🇭FirazyrTakeda Pharma AG
- DKFirazyrTakeda Pharmaceuticals International AG Ireland Branch
- PLFirazyrTakeda Pharmaceuticals International AG Ireland Branch
- ISFirazyrTakeda Pharmaceuticals International AG Ireland Branch
- FIFirazyrAbacus Medicine A/S
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