Technescan Pyp Injection, Powder, Lyophilized, For Solution
NDC Package 69945-094-20

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

Package Information

Technescan Pyp (technetium tc 99m pyrophosphate) injection is technetium Tc 99m Pyrophosphate Injection is a skeletal 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. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Curium Us Llc, this product is identified by NDC 69945-094 and is authorized under FDA application NDA017538.

Identification & Billing

NDC Package Code
69945-094-20
Package Description
5 VIAL in 1 CELLO PACK / 10 mL in 1 VIAL (69945-094-01)
Product Code
69945-094
11-Digit Billing Format
69945009420
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
Technescan Pyp
Non-Proprietary Name
Technetium Tc 99m Pyrophosphate
Substance Name
Sodium Pyrophosphate; Stannous Chloride
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Usage Information
Technetium Tc 99m Pyrophosphate Injection is a skeletal 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. As an adjunct in the diagnosis of confirmed myocardial infarction (ECG and serum enzymes positive), the incidence of false negative images has been found to be 6%. False negative images can also occur if made too early in the evolutionary phase of the infarct or too late in the resolution phase. In a limited study involving 22 patients in whom the ECG was positive and serum enzymes questionable or negative, but in whom the final diagnosis of acute myocardial infarction was made, the incidence of false negative images was 23%. The incidence of false positive images has been found to be 7 to 9%. False positive images have been reported following coronary by-pass graft surgery, in unstable angina pectoris, old myocardial infarcts and in cardiac contusions. Technescan PYP 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 administered intravenously 15 to 30 minutes prior to intravenous administration of sodium pertechnetate Tc 99m for in vivo red blood cell labeling, approximately 75% of the injected activity remains in the blood pool. The modified in vivo/in vitro red blood cell labeling method may also be used for blood pool imaging.

Regulatory & Marketing

Labeler Name
Curium Us Llc
Product Type
Human Prescription Drug
FDA Application #
NDA017538
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-14-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69945-094-20 identifies a specific commercial package of 5 vial in 1 cello pack / 10 ml in 1 vial (69945-094-01) of Technescan Pyp, a human prescription drug labeled by Curium Us Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains sodium pyrophosphate; stannous chloride 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 Curium Us Llc on October 14, 2015. The current certification is valid through December 31, 2026.

How is this Curium Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69945009420. 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 (5-3-2)
69945-094-20
11-Digit CMS (5-4-2)
69945-0094-20

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