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United States · US · US:24201-207_16ef6bfb-9dd3-f4cb-e063-6394a90a22bf
Icatibant
In shortageOrange BookUNIISPLATC B06AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeB06AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1124201207011 SYRINGE, GLASS in 1 CARTON (24201-207-01) / 3 mL in 1 SYRINGE, GLASS
- ndc1124201207033 CARTON in 1 CARTON (24201-207-03) / 1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
325O8467XK
ICATIBANT ACETATE
RxCUI 1294605
Orange Book
A211021
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": "24201-207_16ef6bfb-9dd3-f4cb-e063-6394a90a22bf",
"productndc": "24201-207",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "211021",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 30MG BASE/3ML (EQ 10MG BASE/ML)",
"product_no": "001",
"approval_date": "Mar 9, 2020"
}
],
"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": "ANDA211021",
"marketing_category": "ANDA",
"nonproprietary_name": "icatibant",
"start_marketing_date": "20200309",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code B06AC02.
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- FIFirazyrParanova Oy
- 🇨🇭FirazyrTakeda Pharma AG
- PLFirazyrTakeda Pharmaceuticals International AG Ireland Branch
- 🇺🇸FirazyrTakeda Pharmaceuticals America, Inc.
- NOFirazyrTakeda Pharmaceuticals International AG Ireland Branch
- ISFirazyrTakeda Pharmaceuticals International AG Ireland Branch
- FIFirazyrTakeda Pharmaceuticals International AG Ireland Branch
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