Kit For The Preparation Of Technetium Tc99m Pyrophosphate Injection
NDC Package 45567-0060-2

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

Package Information

Kit For The Preparation Of Technetium Tc99m Pyrophosphate (technetium tc99m pyrophosphate) injection is technetium Tc 99m Pyrophosphate Injection is a bone imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction.Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a blood pool imaging agent which may be used for gated blood pool imaging and for the detection of sites of gastrointestinal bleeding. This formulation utilizes a injection delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 45567-0060 and is authorized under FDA application NDA019039.

Identification & Billing

NDC Package Code
45567-0060-2
Package Description
30 VIAL, MULTI-DOSE in 1 KIT / 10 mL in 1 VIAL, MULTI-DOSE
Product Code
45567-0060
11-Digit Billing Format
45567006002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Kit For The Preparation Of Technetium Tc99m Pyrophosphate
Non-Proprietary Name
Technetium Tc99m Pyrophosphate
Substance Name
Technetium Tc-99m Pyrophosphate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TECHNETIUM TC-99M PYROPHOSPHATE 12 mg/10mL
Pharmacologic Class
Usage Information
Technetium Tc 99m Pyrophosphate Injection is a bone imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction.Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a blood pool imaging agent which may be used for gated blood pool imaging and for the detection of sites of gastrointestinal bleeding. When reconstituted with sterile non-pyrogenic isotonic saline and administered intravenously 30 minutes prior to the intravenous administration of Sodium Pertechnetate Tc 99m Injection, approximately 76% of the injected radioactivity remains in the blood pool.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA019039
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-30-1987
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (45567-0060). Click a package code to view its specific billing and regulatory data.

45567-0060-1
5 VIAL, MULTI-DOSE in 1 KIT / 10 mL in 1 VIAL, MULTI-DOSE

* 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 45567-0060-2 identifies a specific commercial package of 30 vial, multi-dose in 1 kit / 10 ml in 1 vial, multi-dose of Kit For The Preparation Of Technetium Tc99m Pyrophosphate, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection is formulated for intravenous use and contains technetium tc-99m pyrophosphate 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 Sun Pharmaceutical Industries, Inc. on June 30, 1987. The current certification is valid through December 31, 2026.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45567006002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-4-1)
45567-0060-2
11-Digit CMS (5-4-2)
45567-0060-02

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