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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
- ndc1165174880001 VIAL in 1 KIT (65174-880-00) / 1 mL in 1 VIAL
- ndc1165174880251 VIAL in 1 KIT (65174-880-25) / .25 mL in 1 VIAL
- ndc1165174880501 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"
}Related drugs
Other records sharing ATC code V10XA01.
- BECapsion 50 MBq - 3700 MBqCis Bio International
- CADRAXIMAGE SODIUM IODIDE I131 CAPSULES, USP THERAPEUTICJUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA
- CADRAXIMAGE SODIUM IODIDE I131 SOLUTION, USP THERAPEUTICJUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA
- FII-131-C-BCIS bio international
- PLIodopolNarodowe Centrum Badań Jądrowych
- CZIODOPOLNarodowe Centrum Badań Jadrowych, Otwock
- DKMoniyot-131 Capsule TCurium Romania S.R.L.
- DKMoniyot-131 Oral SolutionCurium Romania S.R.L.
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