Sodium Iodide I 131 Diagnostic Capsule
NDC Package 65174-461-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sodium Iodide I 131 Diagnostic (sodium iodide i 131) capsules is sodium Iodide I 131 Capsules Diagnostic is indicated for use in adults for:Assessment of thyroid function using radioactive iodine (RAI) uptake testImaging the thyroid (scintigraphy). This formulation utilizes a capsule delivery system. Marketed by Jubilant Draximage Inc., Dba Jubilant Radiopharma, this product is identified by NDC 65174-461 and is authorized under FDA application NDA021305.

Identification & Billing

NDC Package Code
65174-461-05
Package Description
5 CAPSULE in 1 VIAL
Product Code
65174-461
11-Digit Billing Format
65174046105
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5 EA

Clinical Specifications

Proprietary Name
Sodium Iodide I 131 Diagnostic
Non-Proprietary Name
Sodium Iodide I 131
Substance Name
Sodium Iodide I-131
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM IODIDE I-131 100 mCi/1
Pharmacologic Class
Usage Information
Sodium Iodide I 131 Capsules Diagnostic is indicated for use in adults for:Assessment of thyroid function using radioactive iodine (RAI) uptake testImaging the thyroid (scintigraphy)

Regulatory & Marketing

Labeler Name
Jubilant Draximage Inc., Dba Jubilant Radiopharma
Product Type
Human Prescription Drug
FDA Application #
NDA021305
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2006
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65174-461-05 identifies a specific commercial package of 5 capsule in 1 vial of Sodium Iodide I 131 Diagnostic, a human prescription drug labeled by Jubilant Draximage Inc., Dba Jubilant Radiopharma. This product is billed for "EA" each discreet unit and contains an estimated amount of 5 billable units per package. This capsule is formulated for oral use and contains sodium iodide i-131 as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Jubilant Draximage Inc., Dba Jubilant Radiopharma on May 01, 2006. The current certification is valid through December 31, 2026.

How is this Jubilant Draximage Inc., Dba Jubilant Radiopharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65174046105. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
65174-461-05
11-Digit CMS (5-4-2)
65174-0461-05

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.