Tetrofosmin
NDC 51808-223

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 51808-223?
  4. Tetrofosmin Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Tetrofosmin 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 product. This product entry covers the primary NDC 51808-223 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
51808-223
Proprietary Name:
Tetrofosmin
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Anazaohealth Corporation
Labeler Code:
51808
Product Label ID:
73c67954-938f-4bcc-be48-a5a38094fee3
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
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 51808-223?

The NDC code 51808-223 is assigned by the FDA to the product Tetrofosmin. 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: 51808-223-01, 51808-223-02. 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?

Tetrofosmin is a diagnostic agent used to assess areas of reversible myocardial ischemia in the presence or absence of infracted myocardium and is also used to assess ventricular function.PHYSICAL HALF-LIFE & TARGET ORGANSThe physical half-life of technetium, Tc99m, is 6 hours and has a principal radiation emission of gamma photons with a mean energy of 140 KeV. Estimated Absorbed Radiation Dose (Technetium Tc99m Tetrofosmin Injection) Absorbed radiation doseExerciseRestTarget organrad/mCiµGy/MBqrad/mCiµGy/MBqGall bladder wall0.12333.20.18048.6Upper large intestine0.07520.10.11330.4Bladder wall0.05815.60.07119.3Lower large intestine0.05715.30.08222.2Small intestine0.04512.10.06317.0Kidney0.03910.40.04612.5Salivary glands0.0308.040.04311.6Ovaries0.0297.880.0359.55Uterus0.0277.340.0318.36Bone surface0.0236.230.0215.58Pancreas0.0195.000.0184.98Stomach0.0174.600.0174.63Thyroid0.0164.340.0225.83Adrenals0.0164.320.0154.11Heart wall0.0154.140.0153.93Red marrow0.0154.140.0153.97Spleen0.0154.120.0143.82Muscle0.0133.520.0123.32Testes0.0133.410.0113.05Liver0.0123.220.0154.15Thymus0.0123.110.0092.54Brain0.0102.720.0082.15Lungs0.0082.270.0082.08Skin0.0082.220.0071.91Breasts0.0082.220.0071.83Dose calculations were performed using the standard MIRD method (MIRD Pamphlet No.1 (rev),Society of Nuclear Medicine, 1976).Effective dose equivalents (EDE) were calculated in accordance with ICRP 53 (Ann. ICRP 18 (1-4),1988) and gave values of 8.61 × 10-3 mSV/MBq and 1.12 × 10-2 mSV/MBq after exercise and rest, respectively.

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 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".