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  5. NDC Package Code: 68083-396-01 Magnesium Sulfate

NDC Package 68083-396-01 Magnesium Sulfate

Magnesium Sulfate Heptahydrate Injection, Solution Intravenous - 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:
68083-396-01
Package Description:
24 POUCH in 1 CASE / 1 BAG in 1 POUCH / 50 mL in 1 BAG
Product Code:
68083-396
Proprietary Name:
Magnesium Sulfate
Non-Proprietary Name:
Magnesium Sulfate Heptahydrate
Substance Name:
Magnesium Sulfate Heptahydrate
Usage Information:
Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.
11-Digit NDC Billing Format:
68083039601
NDC to RxNorm Crosswalk:
  • RxCUI: 1658259 - magnesium sulfate 2 GM in 50 ML Injection
  • RxCUI: 1658259 - 50 ML magnesium sulfate 40 MG/ML Injection
  • RxCUI: 1658259 - magnesium sulfate 2 GM per 50 ML Injection
  • RxCUI: 1658262 - magnesium sulfate 4 GM in 100 ML Injection
  • RxCUI: 1658262 - 100 ML magnesium sulfate 40 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Gland Pharma Limited
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • MAGNESIUM SULFATE HEPTAHYDRATE 2 g/50mL
    • 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:
    ANDA213917
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-10-2020
    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 68083-396-01?

    The NDC Packaged Code 68083-396-01 is assigned to a package of 24 pouch in 1 case / 1 bag in 1 pouch / 50 ml in 1 bag of Magnesium Sulfate, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 68083-396 included in the NDC Directory?

    Yes, Magnesium Sulfate with product code 68083-396 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on July 10, 2020 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 68083-396-01?

    The 11-digit format is 68083039601. 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
    5-3-268083-396-015-4-268083-0396-01