I 123 Mibg
NDC Package 51808-103-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

I 123 Mibg is iobenguane is indicated as a radioactive isotope diagnosing for adrenomedullary disorders and neuroendocrine tumors.Tumors, adrenal medulla (diagnosis): I-123 MIBG is used for diagnostic imaging of the adrenal medulla, for the evaluation and localization of intra- and extra-adrenal pheochromocytomas, paragangliomas, and neuroblastomas, as well as for localization of metastatic lesions from these tumors. Marketed by Anazaohealth Corporation, this product is identified by NDC 51808-103.

Identification & Billing

NDC Package Code
51808-103-01
Package Description
1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CONTAINER
Product Code
51808-103
11-Digit Billing Format
51808010301

Clinical Specifications

Proprietary Name
I 123 Mibg Meta Iodobenzylguanidine
Dosage Form
-
Usage Information
Iobenguane is indicated as a radioactive isotope diagnosing for adrenomedullary disorders and neuroendocrine tumors.Tumors, adrenal medulla (diagnosis): I-123 MIBG is used for diagnostic imaging of the adrenal medulla, for the evaluation and localization of intra- and extra-adrenal pheochromocytomas, paragangliomas, and neuroblastomas, as well as for localization of metastatic lesions from these tumors. I-123 MIBG can also be used for confirmation of diagnosis of pheochromocytoma when catecholamine determination tests are unclear.Tumors, carcinoid (diagnosis): I-123 MIBG scintigraphy is used as screening procedures for suspected carcinoid tumors, especially those of intestinal origin.Hyperplasia, adrenal medulla (diagnosis): I-123 MIBG is used in the evaluation of the adrenal medulla for disorders such as medullary hyperplasia in patients at risk of developing medullary disease (e.g., multiple endocrine neoplasia [MEN type 2, MEN type 3]).Carcinoma, thyroid (diagnosis): I-123 MIBG is used for diagnostic imaging of medullary thyroid carcinoma.DISTRIBUTIONAfter intravenous administration, there is rapid uptake of MIBG mainly in the liver, and in lesser amounts in the lungs, heart, and salivary glands. A limited number of patients may show activity in normal adrenals, lung, skeletal, muscle, and blocked thyroid glands. Although the uptake in normal adrenal glands is very low, hyperplastic adrenals and tumors such as pheochromocytoma, neuroblastoma, and other tumors with neurosecretory granules have a relatively higher uptake. Significant clearance of I-123 MIBG from the liver and the spleen occurs within 72 hours. I-123 MIBG—In adrenal medullary tumors: Initial images may be obtained 2 to 3 hours after injection. Images may also be obtained at 18 to 24 hours, and as late as 48 hours post injection. Most pheochromocytomas are visualized at 24 hours. However, due to the short half-life of I-123 MIBG, images may not be possible at times when background (e.g., liver) activity is low and imaging would be optimal. Small amounts of radioactivity used in diagnosis; radiation received is low and considered safe.ELIMINATIONRenal; about 40 to 50% of the injected activity is eliminated within 24 hours and about 70 to 90% within 4 days (mainly as unchanged drug with small amounts of I-123 m-iodohippuric acid [I-123 MIHA], I-123 iodide, and I-123 m-iodobenzoic acid [I-123 MIBA]).

Regulatory & Marketing

Labeler Name
Anazaohealth Corporation
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
05-23-2012
End Marketing Date
07-02-2012
Listing Expiration
07-02-2012
Exclude Flag
D
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 51808-103-01 identifies a specific commercial package of 1 injection, powder, lyophilized, for solution in 1 container of I 123 Mibg Meta Iodobenzylguanidine, labeled by Anazaohealth Corporation. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Anazaohealth Corporation on May 23, 2012. The current certification is valid through July 02, 2012.

How is this Anazaohealth Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51808010301. 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)
51808-103-01
11-Digit CMS (5-4-2)
51808-0103-01

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