🇺🇸
United States · US · US:70709-013_98f58ca8-04a0-4453-adf0-b000d3bcfae1
SAJAZIR
In shortageOrange BookUNIISPLATC B06AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCycle Pharmaceuticals Ltd-Uk
CountryUS (United States)
ATC codeB06AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170709013011 SYRINGE, GLASS in 1 CARTON (70709-013-01) / 3 mL in 1 SYRINGE, GLASS
- ndc1170709013033 SYRINGE, GLASS in 1 CARTON (70709-013-03) / 3 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
325O8467XK
ICATIBANT ACETATE
RxCUI 1294605
Orange Book
A212446
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": {
"1756aca0-21a1-4898-8d6c-9666738db45c": {
"match": "brand_token",
"title": "SAJAZIR (ICATIBANT) INJECTION [CYCLE PHARMACEUTICALS LTD-UK]",
"spl_version": "5",
"published_date": "2024-05-24"
}
},
"productid": "70709-013_98f58ca8-04a0-4453-adf0-b000d3bcfae1",
"productndc": "70709-013",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "212446",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 30MG BASE/3ML (EQ 10MG BASE/ML)",
"product_no": "001",
"approval_date": "Jul 13, 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": "SAJAZIR",
"active_ingred_unit": "mg/3mL",
"application_number": "ANDA212446",
"marketing_category": "ANDA",
"nonproprietary_name": "ICATIBANT",
"start_marketing_date": "20210603",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code B06AC02.
- FIFirazyrParanova Oy
- 🇺🇸FirazyrTakeda Pharmaceuticals America, Inc.
- 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
- FIFirazyrTakeda Pharmaceuticals International AG Ireland Branch
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