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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

  • ndc11
    7070901301
    1 SYRINGE, GLASS in 1 CARTON (70709-013-01) / 3 mL in 1 SYRINGE, GLASS
  • ndc11
    7070901303
    3 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

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