Technelite Injection, Solution
NDC Package 11994-090-07

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

Package Information

Technelite (technetium tc99m generator) injection is the Technelite 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. This formulation utilizes a injection, solution delivery system. Marketed by Lantheus Medical Imaging, Inc., this product is identified by NDC 11994-090 and is authorized under FDA application NDA017771.

Identification & Billing

NDC Package Code
11994-090-07
Package Description
1 VIAL in 1 CARTON / 30 mL in 1 VIAL
Product Code
11-Digit Billing Format
11994009007
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
Technelite
Non-Proprietary Name
Technetium Tc99m Generator
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.
Usage Information
The Technelite 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 Injection is used IN ADULTS as an agent for: Thyroid Imaging Salivary Gland Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux. Nasolacrimal Drainage System ImagingSodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for: Thyroid Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.

Regulatory & Marketing

Labeler Name
Lantheus Medical Imaging, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA017771
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-1975
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 (11994-090). Click a package code to view its specific billing and regulatory data.

1 VIAL in 1 CARTON / 12 mL in 1 VIAL
1 VIAL in 1 CARTON / 16 mL in 1 VIAL
1 VIAL in 1 CARTON / 18 mL in 1 VIAL
1 VIAL in 1 CARTON / 20 mL in 1 VIAL
1 VIAL in 1 CARTON / 24 mL in 1 VIAL
1 VIAL in 1 CARTON / 40 mL in 1 VIAL
1 VIAL in 1 CARTON / 50 mL in 1 VIAL
1 VIAL in 1 CARTON / 60 mL in 1 VIAL
1 VIAL in 1 CARTON / 72 mL in 1 VIAL
1 VIAL in 1 CARTON / 80 mL in 1 VIAL
1 VIAL in 1 CARTON / 4 mL in 1 VIAL
1 VIAL in 1 CARTON / 8 mL in 1 VIAL
1 VIAL in 1 CARTON / 10 mL in 1 VIAL

* 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 11994-090-07 identifies a specific commercial package of 1 vial in 1 carton / 30 ml in 1 vial of Technelite, a human prescription drug labeled by Lantheus Medical Imaging, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Lantheus Medical Imaging, Inc. on November 01, 1975. The current certification is valid through December 31, 2026.

How is this Lantheus Medical Imaging, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11994009007. 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)
11994-090-07
11-Digit CMS (5-4-2)
11994-0090-07

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