1. Home
  2. Labeler Index
  3. Filo America
  4. 50438-001
  5. NDC Package Code: 50438-001-00 Royal Epsom Salt

NDC Package 50438-001-00 Royal Epsom Salt

Magnesium Sulfate Granule, For Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
50438-001-00
Package Description:
1.8 kg in 1 BAG
Product Code:
50438-001
Proprietary Name:
Royal Epsom Salt
Non-Proprietary Name:
Magnesium Sulfate
Substance Name:
Magnesium Sulfate, Unspecified Form
Usage Information:
DirectionsDrink a full glass (8 ounces) of liquid with each dose.The dose may be taken as a single daily dose or in divided doses.1 teaspoon equals 5 grams.Adults and children 12 years and over - Oral dosage is 10 to 30 gramschildren 6 to under 12 years of age - Oral dosage is 5 to 10 gramschildren 2 to under 6 years of age - Oral dosage is 2.5 to 5 gramschildren under 2 years of age - consult a doctor
11-Digit NDC Billing Format:
50438000100
NDC to RxNorm Crosswalk:
  • RxCUI: 1053346 - Epsom salt 100 % Granules for Oral Solution
  • RxCUI: 1053346 - magnesium sulfate 1000 MG Granules for Oral Solution
  • RxCUI: 1053346 - magnesium sulfate 100 % Granules for Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Filo America
    Dosage Form:
    Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • MAGNESIUM SULFATE, UNSPECIFIED FORM 1 kg/kg
    • Pharmacologic Class(es):
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    M007
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    10-29-2014
    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.

    Frequently Asked Questions

    What is NDC 50438-001-00?

    The NDC Packaged Code 50438-001-00 is assigned to a package of 1.8 kg in 1 bag of Royal Epsom Salt, a human over the counter drug labeled by Filo America. The product's dosage form is granule, for solution and is administered via oral form.

    Is NDC 50438-001 included in the NDC Directory?

    Yes, Royal Epsom Salt with product code 50438-001 is active and included in the NDC Directory. The product was first marketed by Filo America on October 29, 2014 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 11-digit format for NDC 50438-001-00?

    The 11-digit format is 50438000100. 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 5-3-2 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
    5-3-250438-001-005-4-250438-0001-00