Hicon, Sodium Iodide I 131

NDA 21305, held by Jubilant. Sodium Iodide I-131.

As of Nov 13, 2026, NDA 21305 (Hicon, Sodium Iodide I 131), held by Jubilant, was first approved by FDA on Jan 24, 2003, with 20 approved supplements and 0 published complete response letters.

First approved: Jan 24, 2003
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Sodium Iodide I 131 Capsules Diagnostic is indicated for use in adults for: Assessment of thyroid function using radioactive iodine (RAI) uptake test Imaging the thyroid (scintigraphy) Sodium Iodide I 131 Capsules Diagnostic is a radioactive diagnostic agent indicated for the assessment of thyroid function and for thyroid imaging.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
May 19, 2005	Supplement 3Efficacy (new indication or use)	Approved	Letter Label
Jan 24, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

6 strengths and forms

Product	Active ingredient	Marketing
Hicon1-250mCi/0.25ML · solution;oral	Sodium Iodide I-131	Discontinued
Hicon1-500mCi/0.5ML · solution;oral	Sodium Iodide I-131	Discontinued
Sodium Iodide I 1312-200mCi · capsule;oral	Sodium Iodide I-131	Discontinued
Hicon1-1000mCi/ML · solution;oral	Sodium Iodide I-131	Discontinued
Sodium Iodide I 1310.009-0.1mCi · capsule;oral	Sodium Iodide I-131	RxReference drug
Hicon250-1000mCi · solution;oral	Sodium Iodide I-131	RxReference drug

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 11, 2021	Supplement 47Labeling · Standard review	Approved	Letter Label
Jul 8, 2016	Supplement 42Labeling · Standard review	Approved	Letter
Jun 15, 2016	Supplement 41Labeling · Standard review	Approved	Letter Label
Apr 1, 2016	Supplement 39Manufacturing · Standard review	Approved	None posted
Jul 31, 2015	Supplement 40Manufacturing · Standard review	Approved	None posted
Feb 3, 2015	Supplement 38Manufacturing · Standard review	Approved	None posted
Sep 26, 2014	Supplement 35Manufacturing · Standard review	Approved	None posted
Dec 7, 2012	Supplement 34Manufacturing · Standard review	Approved	None posted
Dec 7, 2012	Supplement 33Manufacturing · Standard review	Approved	None posted
Oct 3, 2011	Supplement 27Manufacturing · Standard review	Approved	Letter Label
Sep 23, 2011	Supplement 25Labeling · Standard review	Approved	Label Letter
Feb 29, 2008	Supplement 16Labeling · Standard review	Approved	Label Letter
Jan 17, 2008	Supplement 15Manufacturing	Approved	None posted
Apr 18, 2007	Supplement 11Labeling · Standard review	Approved	Letter Label
Oct 23, 2006	Supplement 10Labeling · Standard review	Approved	Letter
Apr 4, 2006	Supplement 8Manufacturing	Approved	None posted
Jan 6, 2006	Supplement 5Labeling · Standard review	Approved	Letter Label
May 19, 2005	Supplement 3Efficacy (new indication or use)	Approved	Letter Label
Nov 18, 2004	Supplement 2Manufacturing · Standard review	Approved	Letter
Aug 8, 2003	Supplement 1Labeling · Standard review	Approved	Letter
Jan 24, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21305
Drugs@FDA: Overview at FDA
Company: Jubilant

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters