Back to search
🇺🇸

United States · US · US:50914-7729_03a98b4c-213b-4537-8d3a-aaa9f9f1cc9b

Glofil-125

Orange BookUNIIATC V09CX03

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

Identification

ManufacturerIso-Tex Diagnostics, Inc.
CountryUS (United States)
ATC codeV09CX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5091477292
    1 VIAL, MULTI-DOSE in 1 BOX (50914-7729-2) / 4 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
31J5U3Q9ZN
IOTHALAMATE SODIUM I-125
RxCUI 91537
Orange Book
N017279
Raw payload (JSON)
{
  "unii": {
    "unii": "31J5U3Q9ZN",
    "rxcui": "91537",
    "inchikey": "WCIMWHNSWLLELS-SQHZOQHUSA-M",
    "display_name": "IOTHALAMATE SODIUM I-125",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "productid": "50914-7729_03a98b4c-213b-4537-8d3a-aaa9f9f1cc9b",
  "productndc": "50914-7729",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "017279",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250-300uCi/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IOTHALAMATE SODIUM I-125",
  "proprietary_name": "Glofil-125",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA017279",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sodium Iothalamate I-125 injection",
  "start_marketing_date": "19830501",
  "active_numerator_strength": ".275"
}

Related drugs

Other records sharing ATC code V09CX03.

Access this data programmatically

Query Glofil-125 and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.