🇺🇸
United States · US · US:55150-351_ff0f66d4-bb7c-43a6-9475-f8d87f21abb4
Icatibant
In shortageOrange BookUNIISPLATC B06AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeB06AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1155150351011 SYRINGE, GLASS in 1 CARTON (55150-351-01) / 3 mL in 1 SYRINGE, GLASS
- ndc1155150351033 CARTON in 1 CARTON (55150-351-03) / 1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
325O8467XK
ICATIBANT ACETATE
RxCUI 1294605
Orange Book
A213521
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": {
"aeb5406c-9501-4f43-8134-5b02a7fa7451": {
"match": "brand_token",
"title": "ICATIBANT INJECTION [ALEMBIC PHARMACEUTICALS INC.]",
"spl_version": "8",
"published_date": "2025-07-03"
}
},
"productid": "55150-351_ff0f66d4-bb7c-43a6-9475-f8d87f21abb4",
"productndc": "55150-351",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "213521",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 30MG BASE/3ML (EQ 10MG BASE/ML)",
"product_no": "001",
"approval_date": "Aug 14, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ICATIBANT ACETATE",
"shortage_reason": "Icatibant Acetate Injection",
"shortage_status": "current",
"proprietary_name": "Icatibant",
"active_ingred_unit": "mg/3mL",
"application_number": "ANDA213521",
"marketing_category": "ANDA",
"nonproprietary_name": "Icatibant",
"start_marketing_date": "20230814",
"active_numerator_strength": "30"
}Related drugs
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- DKFirazyrTakeda Pharmaceuticals International AG Ireland Branch
- PLFirazyrTakeda Pharmaceuticals International AG Ireland Branch
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- FIFirazyrTakeda Pharmaceuticals International AG Ireland Branch
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