NDC 44567-423 Magnesium Sulfate In Water

Magnesium Sulfate Injection Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
44567-423
Proprietary Name:
Magnesium Sulfate In Water
Non-Proprietary Name: [1]
Magnesium Sulfate
Substance Name: [2]
Magnesium Sulfate Heptahydrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Wg Critical Care, Llc
    Labeler Code:
    44567
    FDA Application Number: [6]
    ANDA207350
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    01-09-2018
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 44567-423-10

    Package Description: 10 BAG in 1 CARTON / 1000 mL in 1 BAG

    Product Details

    What is NDC 44567-423?

    The NDC code 44567-423 is assigned by the FDA to the product Magnesium Sulfate In Water which is a human prescription drug product labeled by Wg Critical Care, Llc. The generic name of Magnesium Sulfate In Water is magnesium sulfate. The product's dosage form is injection and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 44567-423-10 10 bag in 1 carton / 1000 ml in 1 bag. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Magnesium Sulfate In Water?

    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.

    What are Magnesium Sulfate In Water Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Magnesium Sulfate In Water UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
    • MAGNESIUM CATION (UNII: T6V3LHY838) (Active Moiety)

    What is the NDC to RxNorm Crosswalk for Magnesium Sulfate In Water?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Magnesium Sulfate In Water?

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".