NDC 10135-583 Magnesium Oxide

Magnesium Oxide

NDC Product Code 10135-583

NDC Code: 10135-583

Proprietary Name: Magnesium Oxide What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Magnesium Oxide 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.


Product Characteristics
Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
11 MM
Imprint(s):
174
Score: 1

Code Structure
  • 10135 - Marlex Pharmaceuticals Inc
    • 10135-583 - Magnesium Oxide

NDC 10135-583-62

Package Description: 120 TABLET in 1 BOTTLE

NDC Product Information

Magnesium Oxide with NDC 10135-583 is a a human over the counter drug product labeled by Marlex Pharmaceuticals Inc. The generic name of Magnesium Oxide is magnesium oxide. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Marlex Pharmaceuticals Inc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug 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.


Magnesium Oxide Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MAGNESIUM OXIDE 400 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Marlex Pharmaceuticals Inc
Labeler Code: 10135
FDA Application Number: part331 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 02-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Magnesium Oxide Product Label Images

Magnesium Oxide Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Tablet)

Magnesium Oxide 400mg (241.3mg elemental magnesium)

Purpose

Antacid

Uses

  • Relievesacid indigestion upset stomach

Warnings

Ask a doctor if you havekidney disease

Ask A Doctor Or Pharmacist Before Use If You Are

Taking a prescription drug. Antacids may interact with certain prescription drugs.Do not takemore than 2 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks, except under the advise and supervision of a physician

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Directions

  • Antacid Directions:take 1 tablet twice a day or as directed by a physicianMagnesium Supplement Directions:take 1 to 2 tablets daily or as directed by a physician

Other Information

  • Magnesium content per tablet: 241.3mgstore at room temperature 59°-86° F (15°-30°C)do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acidManufactured for & Distributed by:Marlex Pharmaceuticals, Inc.New Castle, DE 19720Made in the U.S.A.Rev. 02/19AH

* Please review the disclaimer below.

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