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  4. NDC Product Code: 68462-295 Trandolapril And Verapamil Hydrochloride

NDC 68462-295 Trandolapril And Verapamil Hydrochloride

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68462-295?
  5. Trandolapril And Verapamil Hydrochloride Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
68462-295
Proprietary Name:
Trandolapril And Verapamil Hydrochloride
Non-Proprietary Name: [1]
Trandolapril And Verapamil Hydrochloride
Substance Name: [2]
Trandolapril; Verapamil Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Glenmark Pharmaceuticals Inc., Usa
    Labeler Code:
    68462
    Product Label ID:
    39bad727-af4c-4d20-933b-7f287e88099a
    FDA Application Number: [6]
    ANDA079135
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    02-25-2015
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BROWN (C48332)
    PINK (C48328)
    Shape:
    OVAL (C48345)
    Size(s):
    19 MM
    17 MM
    Imprint(s):
    G38
    295
    Score:
    1

    Product Packages

    NDC Code 68462-295-01

    Package Description: 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    NDC Code 68462-295-10

    Package Description: 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    NDC Code 68462-295-90

    Package Description: 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    Product Details

    What is NDC 68462-295?

    The NDC code 68462-295 is assigned by the FDA to the product Trandolapril And Verapamil Hydrochloride which is a human prescription drug product labeled by Glenmark Pharmaceuticals Inc., Usa. The product's dosage form is tablet, film coated, extended release and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 68462-295-01 100 tablet, film coated, extended release in 1 bottle , 68462-295-10 1000 tablet, film coated, extended release in 1 bottle , 68462-295-90 90 tablet, film coated, extended release in 1 bottle . 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 Trandolapril And Verapamil Hydrochloride?

    Trandolapril and verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension.This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).In using trandolapril and verapamil hydrochloride extended-release tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have similar risk (see WARNINGS - Neutropenia/Agranulocytosis).

    What are Trandolapril And Verapamil Hydrochloride 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 Trandolapril And Verapamil Hydrochloride UNII Codes?

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

    Which are Trandolapril And Verapamil Hydrochloride 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 Trandolapril And Verapamil Hydrochloride?

    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: 897781 - trandolapril 1 MG / verapamil HCl 240 MG 24HR Extended Release Oral Tablet
    • RxCUI: 897781 - 24 HR trandolapril 1 MG / verapamil hydrochloride 240 MG Extended Release Oral Tablet
    • RxCUI: 897781 - trandolapril 1 MG / verapamil hydrochloride 240 MG 24 HR Extended Release Oral Tablet
    • RxCUI: 897783 - trandolapril 2 MG / verapamil HCl 180 MG 24HR Extended Release Oral Tablet
    • RxCUI: 897783 - 24 HR trandolapril 2 MG / verapamil hydrochloride 180 MG Extended Release Oral Tablet

    Which are the Pharmacologic Classes for Trandolapril And Verapamil Hydrochloride?

    * Please review the disclaimer below.

    Patient Education

    Trandolapril and Verapamil


    The combination of trandolapril and verapamil is used to treat high blood pressure. It is a combination of two medications. It decreases certain chemicals that tighten the blood vessels, so blood flows more smoothly. It also relaxes your blood vessels so your heart does not have to pump as hard. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [Learn More]


    Blood Pressure Medicines


    What is high blood pressure?

    High blood pressure, also called hypertension, is when blood puts too much pressure against the walls of your arteries. About 1 in 3 adults have high blood pressure, usually with no symptoms. But it can cause serious problems such as stroke, heart failure, heart attack, and kidney disease.

    What lifestyle changes can help lower high blood pressure?

    Healthy lifestyle changes can help reduce high blood pressure:

    What if lifestyle changes alone cannot lower blood pressure?

    Sometimes lifestyle changes alone cannot control or lower your high blood pressure. In that case, your health care provider may prescribe blood pressure medicines.

    How do blood pressure medicines work?

    Blood pressure medicines work in different ways to lower blood pressure:

    • Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) keep your blood vessels from narrowing as much
    • Calcium channel blockers prevent calcium from entering the muscle cells of your heart and blood vessels. This allows the blood vessels to relax.
    • Diuretics remove extra water and sodium (salt) from your body. This lowers the amount of fluid in your blood. Diuretics are often used with other high blood pressure medicines, sometimes in one combined pill.
    • Beta blockers help your heart beat slower and with less force. This means that your heart pumps less blood through your blood vessels. Beta blockers are typically used only as a backup option or if you also have certain other conditions.

    Often, two or more medicines work better than one. While taking the medicines, it is still important to keep up with your healthy lifestyle changes.

    NIH: National Heart, Lung, and Blood Institute


    [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".