SODIUM IODIDE I-131 - Food and Drug Administration

Set ID: 20ce01ac-ad85-424c-96b9-52d2671eb5b5
Type: Indexing - product concept
Effective date: 2020-06-17
Version: 1
Source: DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
Label	Relation	Manufacturer	Effective
These highlights do not include all the information needed to use SODIUM IODIDE I-131 safely and effectively. See full prescribing information for SODIUM IODIDE I-131. SODIUM IODIDE I-131 (for the preparation of sodium iodide I 131 capsules and solution), therapeutic, for oral use. Initial U.S. Approval: 1971	Product name	Radnostix, Inc.	2026-01-23
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	Product name	Jubilant DraxImage Inc., dba Jubilant Radiopharma	2025-01-21
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	Product name	Jubilant DraxImage Inc., dba Jubilant Radiopharma	2020-08-25
I-131 Mini Caps Medical Professional Information Sheet	Product name	AnazaoHealth Corporation	2012-05-23

NDC, DailyMed label, Manufacturer table
NDC	DailyMed label	Manufacturer
51808-119	I-131 Mini Caps Medical Professional Information Sheet	AnazaoHealth Corporation
51808-119-01	I-131 Mini Caps Medical Professional Information Sheet	AnazaoHealth Corporation
65174-461	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	Jubilant DraxImage Inc., dba Jubilant Radiopharma
65174-461-05	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	Jubilant DraxImage Inc., dba Jubilant Radiopharma
65174-880	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	Jubilant DraxImage Inc., dba Jubilant Radiopharma
65174-880-00	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	Jubilant DraxImage Inc., dba Jubilant Radiopharma
65174-880-25	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	Jubilant DraxImage Inc., dba Jubilant Radiopharma
65174-880-50	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	Jubilant DraxImage Inc., dba Jubilant Radiopharma
69208-000	These highlights do not include all the information needed to use SODIUM IODIDE I-131 safely and effectively. See full prescribing information for SODIUM IODIDE I-131. SODIUM IODIDE I-131 (for the preparation of sodium iodide I 131 capsules and solution), therapeutic, for oral use. Initial U.S. Approval: 1971	Radnostix, Inc.
69208-000-00	These highlights do not include all the information needed to use SODIUM IODIDE I-131 safely and effectively. See full prescribing information for SODIUM IODIDE I-131. SODIUM IODIDE I-131 (for the preparation of sodium iodide I 131 capsules and solution), therapeutic, for oral use. Initial U.S. Approval: 1971	Radnostix, Inc.
69208-002	These highlights do not include all the information needed to use SODIUM IODIDE I-131 safely and effectively. See full prescribing information for SODIUM IODIDE I-131. SODIUM IODIDE I-131 (for the preparation of sodium iodide I 131 capsules and solution), therapeutic, for oral use. Initial U.S. Approval: 1971	Radnostix, Inc.
69208-003	These highlights do not include all the information needed to use SODIUM IODIDE I-131 safely and effectively. See full prescribing information for SODIUM IODIDE I-131. SODIUM IODIDE I-131 (for the preparation of sodium iodide I 131 capsules and solution), therapeutic, for oral use. Initial U.S. Approval: 1971	Radnostix, Inc.
69208-003-15	These highlights do not include all the information needed to use SODIUM IODIDE I-131 safely and effectively. See full prescribing information for SODIUM IODIDE I-131. SODIUM IODIDE I-131 (for the preparation of sodium iodide I 131 capsules and solution), therapeutic, for oral use. Initial U.S. Approval: 1971	Radnostix, Inc.
69208-003-25	These highlights do not include all the information needed to use SODIUM IODIDE I-131 safely and effectively. See full prescribing information for SODIUM IODIDE I-131. SODIUM IODIDE I-131 (for the preparation of sodium iodide I 131 capsules and solution), therapeutic, for oral use. Initial U.S. Approval: 1971	Radnostix, Inc.
69208-003-35	These highlights do not include all the information needed to use SODIUM IODIDE I-131 safely and effectively. See full prescribing information for SODIUM IODIDE I-131. SODIUM IODIDE I-131 (for the preparation of sodium iodide I 131 capsules and solution), therapeutic, for oral use. Initial U.S. Approval: 1971	Radnostix, Inc.