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  5. NDC Package Code: 0115-4411-03 Dantrolene Sodium

NDC Package 0115-4411-03 Dantrolene Sodium

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0115-4411-03
Package Description:
1000 CAPSULE in 1 BOTTLE
Product Code:
0115-4411
Proprietary Name:
Dantrolene Sodium
Non-Proprietary Name:
Dantrolene Sodium
Substance Name:
Dantrolene Sodium
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.
11-Digit NDC Billing Format:
00115441103
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1000 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 856652 - dantrolene sodium 100 MG Oral Capsule
  • RxCUI: 856656 - dantrolene sodium 25 MG Oral Capsule
  • RxCUI: 856660 - dantrolene sodium 50 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Of New York Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DANTROLENE SODIUM 25 mg/1
    • Pharmacologic Class(es):
  • Decreased Striated Muscle Contraction - [PE] (Physiologic Effect)
  • Decreased Striated Muscle Tone - [PE] (Physiologic Effect)
  • Skeletal Muscle Relaxant - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA076856
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-01-2005
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0115-4411-01100 CAPSULE in 1 BOTTLE
    0115-4411-02500 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0115-4411-03?

    The NDC Packaged Code 0115-4411-03 is assigned to a package of 1000 capsule in 1 bottle of Dantrolene Sodium, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is capsule and is administered via oral form.

    Is NDC 0115-4411 included in the NDC Directory?

    Yes, Dantrolene Sodium with product code 0115-4411 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Of New York Llc on March 01, 2005 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0115-4411-03?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1000.

    What is the 11-digit format for NDC 0115-4411-03?

    The 11-digit format is 00115441103. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20115-4411-035-4-200115-4411-03