Dantrolene Sodium Capsule
NDC Package 70518-4668-0

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

Package Information

Dantrolene Sodium capsules 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 capsule delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4668 and is authorized under FDA application NDA017443.

Identification & Billing

NDC Package Code
70518-4668-0
Package Description
50 POUCH in 1 BOX / 1 CAPSULE in 1 POUCH (70518-4668-1)
Product Code
70518-4668
11-Digit Billing Format
70518466800
RxNorm Crosswalk
RxCUI: 856660 - dantrolene sodium 50 MG Oral Capsule

Clinical Specifications

Proprietary Name
Dantrolene Sodium
Non-Proprietary Name
Dantrolene Sodium
Substance Name
Dantrolene Sodium
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DANTROLENE SODIUM 50 mg/1
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
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA017443
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
05-27-2026
Listing Expiration
12-31-2027
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 70518-4668-0 identifies a specific commercial package of 50 pouch in 1 box / 1 capsule in 1 pouch (70518-4668-1) of Dantrolene Sodium, a human prescription drug labeled by Remedyrepack Inc.. This capsule is formulated for oral 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 Remedyrepack Inc. on May 27, 2026. The current certification is valid through December 31, 2027.

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 Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518466800. 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 (5-4-1)
70518-4668-0
11-Digit CMS (5-4-2)
70518-4668-00

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