Tetrofosmin
NDC Package 51808-223-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

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

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. Marketed by Anazaohealth Corporation, this product is identified by NDC 51808-223.

Identification & Billing

NDC Package Code
51808-223-01
Package Description
1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT
Product Code
11-Digit Billing Format
51808022301

Clinical Specifications

Proprietary Name
Tetrofosmin
Dosage Form
-
Usage Information
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.

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
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51808-223). Click a package code to view its specific billing and regulatory data.

1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT

* 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 51808-223-01 identifies a specific commercial package of 1 injection, powder, lyophilized, for solution in 1 kit of Tetrofosmin, 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 December 31, 2017.

How is this Anazaohealth Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51808022301. 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)
51808-223-01
11-Digit CMS (5-4-2)
51808-0223-01

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