HICON
These highlights do not include all the information needed to use HICON safely and effectively. See full prescribing information for HICON.HICON (for the preparation of sodium iodide I 131 solution or sodium iodide I 131 capsules), therapeutic, for oral use.Initial U.S. Approval: 1971
Approved
Approval ID
524a0dac-6e2b-2c0c-04b4-76d85dba63c5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 17, 2022
Manufacturers
FDA
Jubilant DraxImage Inc., dba Jubilant Radiopharma
DUNS: 243604761
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Iodide I 131
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65174-880
Application NumberNDA021305
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium Iodide I 131
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 2022
FDA Product Classification
INGREDIENTS (4)
SODIUM IODIDE I-131Active
Quantity: 1000 mCi in 1 mL
Code: 29VCO8ACHH
Classification: ACTIM
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
Sodium ThiosulfateInactive
Code: HX1032V43M
Classification: IACT