🇺🇸
United States · US · US:0093-3066_56c3b3d7-5c66-422c-a72d-30b3599d71db
Icatibant
In shortageOrange BookUNIISPLATC B06AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeB06AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100933066341 SYRINGE in 1 CARTON (0093-3066-34) / 3 mL in 1 SYRINGE
- ndc1100933066933 CARTON in 1 BOX (0093-3066-93) / 1 SYRINGE in 1 CARTON (0093-3066-19) / 3 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
325O8467XK
ICATIBANT ACETATE
RxCUI 1294605
Orange Book
A210118
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": "0093-3066_56c3b3d7-5c66-422c-a72d-30b3599d71db",
"productndc": "0093-3066",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "210118",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 30MG BASE/3ML (EQ 10MG BASE/ML)",
"product_no": "001",
"approval_date": "Jul 15, 2019"
}
],
"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": "ANDA210118",
"marketing_category": "ANDA",
"nonproprietary_name": "Icatibant",
"start_marketing_date": "20190715",
"active_numerator_strength": "10"
}Related drugs
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- PLFirazyrTakeda Pharmaceuticals International AG Ireland Branch
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- FIFirazyrTakeda Pharmaceuticals International AG Ireland Branch
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