Sodium Iodide I 123

NDA 18671, held by Cardinal Health 418. Sodium Iodide I-123.

As of Nov 14, 2026, NDA 18671 (Sodium Iodide I 123), held by Cardinal Health 418, was first approved by FDA on May 27, 1982, with 11 approved supplements and 0 published complete response letters.

First approved: May 27, 1982
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATION AND USE Administration of Sodium Iodide I 123 is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
May 27, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Sodium Iodide I 123100uCi · capsule;oral	Sodium Iodide I-123	RxReference drug
Sodium Iodide I 123200uCi · capsule;oral	Sodium Iodide I-123	RxReference drug
Sodium Iodide I 123400uCi · capsule;oral	Sodium Iodide I-123	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jun 13, 2008	Supplement 16Labeling · Standard review	Approved	Label Letter
Oct 19, 2000	Supplement 10Labeling · Standard review	Approved	None posted
Feb 2, 1998	Supplement 9Labeling · Standard review	Approved	None posted
Jan 23, 1998	Supplement 8Labeling · Standard review	Approved	None posted
Nov 4, 1997	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 28, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 17, 1994	Supplement 5Labeling	Approved	None posted
Jul 12, 1988	Supplement 4Labeling	Approved	None posted
Dec 31, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 9, 1985	Supplement 1Labeling	Approved	None posted
Jul 12, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
May 27, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18671
Drugs@FDA: Overview at FDA
Company: Cardinal Health 418

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