NDC 72578-064 Ranolazine

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

Product Information

NDC Product Code:
72578-064
Proprietary Name:
Ranolazine
Non-Proprietary Name: [1]
Ranolazine
Substance Name: [2]
Ranolazine
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 Code:
    72578
    FDA Application Number: [6]
    ANDA210188
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    09-10-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    ORANGE (C48331 - LIGHT ORANGE)
    Shape:
    OVAL (C48345)
    Size(s):
    17 MM
    Imprint(s):
    588
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 72578-064?

    The NDC code 72578-064 is assigned by the FDA to the product Ranolazine which is a human prescription drug product labeled by Viona Pharmaceuticals Inc. The product's dosage form is tablet, extended release and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 72578-064-01 100 tablet, extended release in 1 bottle , 72578-064-05 500 tablet, extended release in 1 bottle , 72578-064-14 60 tablet, extended release in 1 bottle , 72578-064-77 10 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack (72578-064-30). 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 Ranolazine?

    Ranolazine is used to treat a certain type of chest pain (chronic stable angina). It decreases the number of times you may get chest pain. Relieving symptoms of angina can increase your ability to exercise and perform strenuous work. Ranolazine works differently than other drugs for angina, so it can be used with your other angina medications (including nitrates, calcium channel blockers such as amlodipine, beta blockers such as metoprolol). It is thought to work by improving how well the heart uses oxygen so that it can do more work with less oxygen.

    What are Ranolazine 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.
    • RANOLAZINE 500 mg/1 - An acetanilide and piperazine derivative that functions as a SODIUM CHANNEL BLOCKER and prevents the release of enzymes during MYOCARDIAL ISCHEMIA. It is used in the treatment of ANGINA PECTORIS.

    Which are Ranolazine UNII Codes?

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

    Which are Ranolazine 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 Ranolazine?

    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: 616749 - ranolazine 500 MG 12HR Extended Release Oral Tablet
    • RxCUI: 616749 - 12 HR ranolazine 500 MG Extended Release Oral Tablet
    • RxCUI: 616749 - ranolazine 500 MG 12 HR Extended Release Oral Tablet
    • RxCUI: 728231 - ranolazine 1000 MG 12HR Extended Release Oral Tablet
    • RxCUI: 728231 - 12 HR ranolazine 1000 MG Extended Release Oral Tablet

    Which are the Pharmacologic Classes for Ranolazine?

    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

    Ranolazine


    Ranolazine is used alone or with other medications to treat chronic angina (ongoing chest pain or pressure that is felt when the heart does not get enough oxygen). Ranolazine is in a class of medications called anti-anginals. The exact way that ranolazine works is not known at this time.
    [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".