🇺🇸
United States · US · US:63323-574_d1c9afa7-c4ac-4739-85f1-2ae82440210c
Icatibant
In shortageOrange BookUNIISPLATC B06AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeB06AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1163323574861 SYRINGE in 1 CARTON (63323-574-86) / 3 mL in 1 SYRINGE (63323-574-01)
- ndc1163323574933 CARTON in 1 BOX (63323-574-93) / 1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
325O8467XK
ICATIBANT ACETATE
RxCUI 1294605
Orange Book
A208317
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": "63323-574_d1c9afa7-c4ac-4739-85f1-2ae82440210c",
"productndc": "63323-574",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "208317",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 30MG BASE/3ML (EQ 10MG BASE/ML)",
"product_no": "001",
"approval_date": "Jun 18, 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/mL",
"application_number": "ANDA208317",
"marketing_category": "ANDA",
"nonproprietary_name": "Icatibant",
"start_marketing_date": "20201115",
"active_numerator_strength": "10"
}Related drugs
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