I 123 Mibg
NDC 51808-103

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 51808-103?
  5. I 123 Mibg Meta Iodobenzylguanidine Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

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

I 123 Mibg is a UNAPPROVED DRUG OTHER-approved product labeled by Anazaohealth Corporation. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 51808-103 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
51808-103
Proprietary Name:
I 123 Mibg Meta Iodobenzylguanidine
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Anazaohealth Corporation
Labeler Code:
51808
Product Label ID:
8fc6228a-faf3-4ba7-80e1-ff56ae934383
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
05-23-2012
End Marketing Date: [10]
07-02-2012
Listing Expiration Date: [11]
07-02-2012
Exclude Flag: [12]
D

Product Characteristics

Color(s):
WHITE (C48325 - WHITE POWDER)
Score:
1
Contains:

Code Structure Chart

Product Details

What is NDC 51808-103?

The NDC code 51808-103 is assigned by the FDA to the product I 123 Mibg Meta Iodobenzylguanidine. This pharmaceutical product is labeled by Anazaohealth Corporation and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 51808-103-01, 51808-103-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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]).

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".