Sodium Iodide I 131 Diagnostic
These highlights do not include all the information needed to use SODIUM IODIDE I 131 CAPSULES DIAGNOSTIC safely and effectively. See full prescribing information for SODIUM IODIDE I 131 CAPSULES DIAGNOSTIC. SODIUM IODIDE I 131 capsules, diagnostic, for oral use.Initial U.S. Approval: 1971
Approved
Approval ID
46b8d7ba-432d-d610-84f2-550bf9d0bae3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2020
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 Code65174-461
Application NumberNDA021305
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium Iodide I 131
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2016
FDA Product Classification
INGREDIENTS (4)
Sodium Iodide I-131Active
Quantity: 100 mCi in 1 1
Code: 29VCO8ACHH
Classification: ACTIM
Sodium ThiosulfateInactive
Code: HX1032V43M
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Sodium Phosphate, Dibasic, AnhydrousInactive
Code: 22ADO53M6F
Classification: IACT