Ultra-technekow Injection, Solution
NDC Package 69945-030-07

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

Package Information

Ultra-technekow (technetium tc-99m) injection is the Ultra-Technekow™ V4 generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits.Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for:     Thyroid Imaging     Salivary Gland Imaging     Urinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral reflux     Nasolacrimal Drainage System Imaging (dacryoscintigraphy)Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTS as an agent for:     Thyroid Imaging     Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux. This formulation utilizes a injection, solution delivery system. Marketed by Curium Us Llc, this product is identified by NDC 69945-030 and is authorized under FDA application NDA017243.

Identification & Billing

NDC Package Code
69945-030-07
Package Description
1 INJECTION, SOLUTION in 1 CARTON
Product Code
69945-030
11-Digit Billing Format
69945003007

Clinical Specifications

Proprietary Name
Ultra-technekow V4
Non-Proprietary Name
Technetium Tc-99m
Substance Name
Technetium Tc-99m Sodium Pertechnetate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TECHNETIUM TC-99M SODIUM PERTECHNETATE 3 Ci/1
Usage Information
The Ultra-Technekow™ V4 generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits.Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for:     Thyroid Imaging     Salivary Gland Imaging     Urinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral reflux     Nasolacrimal Drainage System Imaging (dacryoscintigraphy)Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTS as an agent for:     Thyroid Imaging     Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux

Regulatory & Marketing

Labeler Name
Curium Us Llc
Product Type
Human Prescription Drug
FDA Application #
NDA017243
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-10-2014
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 69945-030-07 identifies a specific commercial package of 1 injection, solution in 1 carton of Ultra-technekow V4, a human prescription drug labeled by Curium Us Llc. This injection, solution is formulated for intravenous use and contains technetium tc-99m sodium pertechnetate 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 June 10, 2014. 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: 69945003007. 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)
69945-030-07
11-Digit CMS (5-4-2)
69945-0030-07

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