HICON

Product NDC
65174-880
11-digit product format
651740880
Labeler code
65174
Product ID
65174-880_4e98b8e6-01d4-48e8-87c4-7c6867279fa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Iodide I 131
Dosage form
SOLUTION
Route
ORAL
Labeler
Jubilant DraxImage Inc., dba Jubilant Radiopharma
Application
NDA021305
Marketing category
NDA
Marketing start
2003-04-07
Substance
SODIUM IODIDE I-131
Active strength
1000 mCi/mL
Pharmacologic classes
Radioactive Therapeutic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HICON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM IODIDE I-1311000 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii29VCO8ACHH

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
20ce01ac-ad85-424c-96b9-52d2671eb5b5Product name120200617
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65174-880-00HICON1 mL in 1 VIALSOLUTION110
65174-880-00HICON1 in 1 KITSOLUTION110
65174-880-25HICON.25 mL in 1 VIALSOLUTION.2510
65174-880-25HICON1 in 1 KITSOLUTION110
65174-880-50HICON1 in 1 KITSOLUTION110
65174-880-50HICON.5 mL in 1 VIALSOLUTION.510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65174-880-00EA - Each65174-880d560ad90-2027-479b-b682-de090508ea8c12021-01-08
65174-880-25EA - Each65174-880f5ab758d-bbc2-4f71-83cd-fc45911f7a0412021-01-08
65174-880-50EA - Each65174-880822420a3-81fd-498b-97b1-7d12b14def8612021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium Iodide I-131ACTIVE INGREDIENT29VCO8ACHHHICON (SODIUM IODIDE I 131) SOLUTION [JUBILANT DRAXIMAGE INC.]2
Iodine I-131ACTIVE MOIETYI5X6L61HUTHICON (SODIUM IODIDE I 131) SOLUTION [JUBILANT DRAXIMAGE INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KHICON (SODIUM IODIDE I 131) SOLUTION [JUBILANT DRAXIMAGE INC.]2
Sodium Phosphate, Dibasic AnhydrousINACTIVE INGREDIENT22ADO53M6FHICON (SODIUM IODIDE I 131) SOLUTION [JUBILANT DRAXIMAGE INC.]2
Sodium ThiosulfateINACTIVE INGREDIENTHX1032V43MHICON (SODIUM IODIDE I 131) SOLUTION [JUBILANT DRAXIMAGE INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65174-880HICON (SODIUM IODIDE I 131) SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA]10Current NDC, Legacy NDC, 6 package rows20250131_524a0dac-6e2b-2c0c-04b4-76d85dba63c5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65174-880-00651740880001 VIAL in 1 KIT (65174-880-00) / 1 mL in 1 VIAL1 vial2003-04-070000-00-00NoNoCurrent
65174-880-25651740880251 VIAL in 1 KIT (65174-880-25) / .25 mL in 1 VIAL1 vial2003-04-070000-00-00NoNoCurrent
65174-880-50651740880501 VIAL in 1 KIT (65174-880-50) / .5 mL in 1 VIAL1 vial2003-04-070000-00-00NoNoCurrent