NDC 55154-7291 Isosorbide Mononitrate

Tablet, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
55154-7291
Proprietary Name:
Isosorbide Mononitrate
Non-Proprietary Name: [1]
Isosorbide Mononitrate
Substance Name: [2]
Isosorbide Mononitrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Cardinal Health 107, Llc
    Labeler Code:
    55154
    FDA Application Number: [6]
    ANDA200270
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    01-05-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF-WHITE)
    Shape:
    OVAL (C48345)
    Size(s):
    9 MM
    Imprint(s):
    3;0;1104
    Score:
    2

    Product Packages

    NDC Code 55154-7291-0

    Package Description: 10 BLISTER PACK in 1 BAG / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

    Product Details

    What is NDC 55154-7291?

    The NDC code 55154-7291 is assigned by the FDA to the product Isosorbide Mononitrate which is a human prescription drug product labeled by Cardinal Health 107, Llc. The product's dosage form is tablet, extended release and is administered via oral form. The product is distributed in a single package with assigned NDC code 55154-7291-0 10 blister pack in 1 bag / 1 tablet, extended release in 1 blister pack. 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 Isosorbide Mononitrate?

    Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This medication belongs to a class of drugs known as nitrates. It works by relaxing and widening blood vessels so blood can flow more easily to the heart. This medication will not relieve chest pain once it occurs. Also, it is not intended to be taken just before physical activities (such as exercise or sexual intercourse) to prevent chest pain. Other medications may be prescribed by your doctor for these conditions. Consult your doctor for more details.

    What are Isosorbide Mononitrate 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 Isosorbide Mononitrate UNII Codes?

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

    • ISOSORBIDE MONONITRATE (UNII: LX1OH63030)
    • ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (Active Moiety)

    Which are Isosorbide Mononitrate 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 Isosorbide Mononitrate?

    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: 317110 - isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet
    • RxCUI: 317110 - 24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet
    • RxCUI: 317110 - isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet
    • RxCUI: 353538 - isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet
    • RxCUI: 353538 - 24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet

    Which are the Pharmacologic Classes for Isosorbide Mononitrate?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Isosorbide


    Isosorbide immediate-release tablets are used for the management of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Isosorbide extended-release (long-acting) tablets and extended-release capsules are used for the management of chest pain in people who have coronary artery disease. Isosorbide can only be used to prevent angina; it cannot be used to treat an episode of angina once it has begun. Isosorbide is in a class of medications called vasodilators. It works by relaxing the blood vessels so the heart does not need to work as hard and therefore does not need as much oxygen.
    [Learn More]


    * 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".