Kit For The Preparation Of Technetium Tc 99m Pentetate Injection, Powder, Lyophilized, For Solution
NDC Package 69945-314-30

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 Tc 99m Pentetate injection is after radiolabeling with Technetium Tc 99m, is indicated for. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Curium Us Llc, this product is identified by NDC 69945-314 and is authorized under FDA application ANDA215146.

Identification & Billing

NDC Package Code
69945-314-30
Package Description
30 VIAL in 1 CARTON / 10 mL in 1 VIAL (69945-314-01)
Product Code
69945-314
11-Digit Billing Format
69945031430

Clinical Specifications

Proprietary Name
Kit For The Preparation Of Technetium Tc 99m Pentetate
Non-Proprietary Name
Kit For The Preparation Of Technetium Tc 99m Pentetate
Substance Name
Pentetic Acid
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.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
PENTETIC ACID 20 mg/mL
Pharmacologic Class
Usage Information
Kit for the Preparation of Technetium Tc 99m Pentetate Injection, after radiolabeling with Technetium Tc 99m, is indicated for

Regulatory & Marketing

Labeler Name
Curium Us Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA215146
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-08-2025
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 (69945-314). Click a package code to view its specific billing and regulatory data.

69945-314-05
5 VIAL in 1 KIT / 10 mL in 1 VIAL (69945-314-01)

* 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 69945-314-30 identifies a specific commercial package of 30 vial in 1 carton / 10 ml in 1 vial (69945-314-01) of Kit For The Preparation Of Technetium Tc 99m Pentetate, a human prescription drug labeled by Curium Us Llc. This injection, powder, lyophilized, for solution is formulated for intravenous; respiratory (inhalation) use and contains pentetic acid 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 April 08, 2025. 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: 69945031430. 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)
69945-314-30
11-Digit CMS (5-4-2)
69945-0314-30

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