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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
- ndc1150914772921 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.
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