NDC 51662-1235 50% Magnesium Sulfate

Injection, Solution Intramuscular; Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
51662-1235
Proprietary Name:
50% Magnesium Sulfate
Non-Proprietary Name: [1]
50% 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, 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): [4]
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Hf Acquisition Co. Llc, Dba Health First
    Labeler Code:
    51662
    FDA Application Number: [6]
    ANDA075151
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    08-25-2018
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 51662-1235-1

    Package Description: 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC

    NDC Code 51662-1235-3

    Package Description: 10 POUCH in 1 CASE / 1 CARTON in 1 POUCH (51662-1235-2) / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC

    Product Details

    What is NDC 51662-1235?

    The NDC code 51662-1235 is assigned by the FDA to the product 50% Magnesium Sulfate which is a human prescription drug product labeled by Hf Acquisition Co. Llc, Dba Health First. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form. The product is distributed in 2 packages with assigned NDC codes 51662-1235-1 1 syringe, plastic in 1 carton / 10 ml in 1 syringe, plastic, 51662-1235-3 10 pouch in 1 case / 1 carton in 1 pouch (51662-1235-2) / 1 syringe, plastic in 1 carton / 10 ml in 1 syringe, plastic. 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 50% Magnesium Sulfate?

    Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum magnesium (Mg++) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca++) level is normal (4.3 to 5.3 mEq/liter) or elevated.In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.Magnesium Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.

    What are 50% Magnesium Sulfate 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 50% Magnesium Sulfate UNII Codes?

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

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

    Which are 50% Magnesium Sulfate Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for 50% Magnesium Sulfate?

    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:
    • RxCUI: 829762 - magnesium sulfate 5 GM in 10 ML Prefilled Syringe
    • RxCUI: 829762 - 10 ML magnesium sulfate 500 MG/ML Prefilled Syringe
    • RxCUI: 829762 - magnesium sulfate 5 GM per 10 ML (4 mEq/ML) Prefilled Syringe
    • RxCUI: 829762 - magnesium sulfate 5 GM per 10 ML Prefilled Syringe

    Which are the Pharmacologic Classes for 50% Magnesium Sulfate?

    * 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".