Revonto Injection, Powder, Lyophilized, For Solution
NDC Package 84549-003-67

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

Package Information

Revonto (dantrolene sodium) injection is a medication used to treat muscle tightness and cramping (spasms) caused by certain nerve disorders such as spinal cord injury, stroke, cerebral palsy, and multiple sclerosis. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Propharma Distribution, this product is identified by NDC 84549-003 and is authorized under FDA application ANDA078378.

Identification & Billing

NDC Package Code
84549-003-67
Package Description
60 mL in 1 VIAL, GLASS
Product Code
84549-003
11-Digit Billing Format
84549000367
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Revonto
Non-Proprietary Name
Dantrolene Sodium
Substance Name
Dantrolene Sodium
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)
DANTROLENE SODIUM 20 mg/60mL
Pharmacologic Class
Usage Information
This medication is used to treat muscle tightness and cramping (spasms) caused by certain nerve disorders such as spinal cord injury, stroke, cerebral palsy, and multiple sclerosis. It works by relaxing the muscles. Dantrolene helps reduce muscle pain and stiffness, improves your ability to move around, and lets you do more of your daily activities. Dantrolene is also used with other treatments to prevent or treat special cases of high fever (malignant hyperthermia) related to anesthesia and surgery.

Regulatory & Marketing

Labeler Name
Propharma Distribution
Product Type
Human Prescription Drug
FDA Application #
ANDA078378
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-09-2021
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 84549-003-67 identifies a specific commercial package of 60 ml in 1 vial, glass of Revonto, a human prescription drug labeled by Propharma Distribution. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains dantrolene sodium 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 Propharma Distribution on April 09, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat muscle tightness and cramping (spasms) caused by certain nerve disorders such as spinal cord injury, stroke, cerebral palsy, and multiple sclerosis. It works by relaxing the muscles. Dantrolene helps reduce muscle pain and stiffness, improves your ability to move around, and lets you do more of your daily activities. Dantrolene is also used with other treatments to prevent or treat special cases of high fever (malignant hyperthermia) related to anesthesia and surgery.

How is this Propharma Distribution product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84549000367. 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)
84549-003-67
11-Digit CMS (5-4-2)
84549-0003-67

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