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United States · US · US:65174-880_4e98b8e6-01d4-48e8-87c4-7c6867279fa4

HICON

In shortageOrange BookUNIISPLATC V10XA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerJubilant DraxImage Inc., dba Jubilant Radiopharma
CountryUS (United States)
ATC codeV10XA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6517488000
    1 VIAL in 1 KIT (65174-880-00) / 1 mL in 1 VIAL
  • ndc11
    6517488025
    1 VIAL in 1 KIT (65174-880-25) / .25 mL in 1 VIAL
  • ndc11
    6517488050
    1 VIAL in 1 KIT (65174-880-50) / .5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
29VCO8ACHH
SODIUM IODIDE I-131
RxCUI 91535
Orange Book
N021305
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Bicarbonate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "29VCO8ACHH",
    "rxcui": "91535",
    "inchikey": "FVAUCKIRQBBSSJ-LAIFMVDKSA-M",
    "display_name": "SODIUM IODIDE I-131",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "524a0dac-6e2b-2c0c-04b4-76d85dba63c5": {
      "match": "brand_token",
      "title": "HICON (SODIUM IODIDE I 131) SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA]",
      "spl_version": "10",
      "published_date": "2025-01-31"
    }
  },
  "productid": "65174-880_4e98b8e6-01d4-48e8-87c4-7c6867279fa4",
  "productndc": "65174-880",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "021305",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1-250mCi/0.25ML",
        "product_no": "002",
        "approval_date": "Jan 24, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1-500mCi/0.5ML",
        "product_no": "003",
        "approval_date": "Jan 24, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2-200mCi",
        "product_no": "004",
        "approval_date": "Nov 18, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1-1000mCi/ML",
        "product_no": "005",
        "approval_date": "Apr 4, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.009-0.1mCi",
        "product_no": "006",
        "approval_date": "May 19, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "250-1000mCi",
        "product_no": "007",
        "approval_date": "Dec 5, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM IODIDE I-131",
  "shortage_reason": "Sodium Bicarbonate Injection",
  "shortage_status": "current",
  "proprietary_name": "HICON",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA021305",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sodium Iodide I 131",
  "start_marketing_date": "20030407",
  "active_numerator_strength": "1000"
}

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