Dantrolene Sodium Capsule
NDC Package 0115-4433-01

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

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 Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 0115-4433 and is authorized under FDA application ANDA076856.

Identification & Billing

NDC Package Code
0115-4433-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
0115-4433
11-Digit Billing Format
00115443301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

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 100 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
Amneal Pharmaceuticals Of New York Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA076856
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2005
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0115-4433). Click a package code to view its specific billing and regulatory data.

0115-4433-02
500 CAPSULE in 1 BOTTLE
0115-4433-03
1000 CAPSULE in 1 BOTTLE

* 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 0115-4433-01 identifies a specific commercial package of 100 capsule in 1 bottle of Dantrolene Sodium, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. 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 Amneal Pharmaceuticals Of New York Llc on March 01, 2005. 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 Amneal Pharmaceuticals Of New York Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00115443301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (4-4-2)
0115-4433-01
11-Digit CMS (5-4-2)
00115-4433-01

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