Definity Rt Injection, Suspension
NDC Package 11994-017-01

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

Definity Rt (perflutren) injection is activated DEFINITY RT (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. This formulation utilizes a injection, suspension delivery system. Marketed by Lantheus Medical Imaging, Inc., this product is identified by NDC 11994-017 and is authorized under FDA application NDA021064.

Identification & Billing

NDC Package Code
11994-017-01
Package Description
1 VIAL, GLASS in 1 CARTON / .35 mL in 1 VIAL, GLASS
Product Code
11994-017
11-Digit Billing Format
11994001701
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Definity Rt
Non-Proprietary Name
Perflutren
Substance Name
Perflutren
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
PERFLUTREN 6.52 mg/mL
Pharmacologic Class
Usage Information
Activated DEFINITY RT (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

Regulatory & Marketing

Labeler Name
Lantheus Medical Imaging, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021064
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-2020
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 (11994-017). Click a package code to view its specific billing and regulatory data.

11994-017-20
20 VIAL, GLASS in 1 CARTON / .35 mL in 1 VIAL, GLASS

* 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 11994-017-01 identifies a specific commercial package of 1 vial, glass in 1 carton / .35 ml in 1 vial, glass of Definity Rt, a human prescription drug labeled by Lantheus Medical Imaging, Inc.. This injection, suspension is formulated for intravenous use and contains perflutren 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 October 01, 2020. 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: 11994001701. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
11994-017-01
11-Digit CMS (5-4-2)
11994-0017-01

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