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  2. Novartis Pharmaceuticals Corporation
  3. NDC Product Code: 0078-0406 Lotrel

NDC 0078-0406 Lotrel

Amlodipine Besylate And Benazepril Hydrochloride Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0078-0406?
    5. Lotrel 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:
0078-0406
Proprietary Name:
Lotrel
Non-Proprietary Name: [1]
Amlodipine Besylate And Benazepril Hydrochloride
Substance Name: [2]
Amlodipine Besylate; Benazepril Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Novartis Pharmaceuticals Corporation
    Labeler Code:
    0078
    Product Label ID:
    94ae6054-b7ae-4212-a567-4f803af8f2c7
    FDA Application Number: [6]
    NDA020364
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    03-03-1995
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BROWN (C48332 - LIGHT BROWN WITH 2 WHITE BANDS)
    PINK (C48328 - PINK WITH 2 WHITE BANDS)
    Shape:
    CAPSULE (C48336)
    Size(s):
    19 MM
    Imprint(s):
    LOTREL;2260
    LOTREL;2265
    Score:
    1

    Product Packages

    NDC Code 0078-0406-05

    Package Description: 100 CAPSULE in 1 BOTTLE

    Price per Unit: $9.66662 per EA

    Product Details

    What is NDC 0078-0406?

    The NDC code 0078-0406 is assigned by the FDA to the product Lotrel which is a human prescription drug product labeled by Novartis Pharmaceuticals Corporation. The generic name of Lotrel is amlodipine besylate and benazepril hydrochloride. The product's dosage form is capsule and is administered via oral form. The product is distributed in a single package with assigned NDC code 0078-0406-05 100 capsule 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 Lotrel?

    This product is a combination of two drugs: a calcium channel blocker (amlodipine) and an ACE inhibitor (benazepril). It is used to treat high blood pressure. It works by relaxing blood vessels so that blood can flow more easily. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems.

    What are Lotrel 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 Lotrel UNII Codes?

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

    Which are Lotrel 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 Lotrel?

    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: 898342 - amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral Capsule
    • RxCUI: 898342 - amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule
    • RxCUI: 898342 - amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral Capsule
    • RxCUI: 898342 - Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule
    • RxCUI: 898344 - Lotrel 10 MG / 20 MG Oral Capsule

    * Please review the disclaimer below.

    Patient Education

    Amlodipine and Benazepril


    The combination of amlodipine and benazepril is used to treat high blood pressure. Amlodipine is in a class of medications called calcium channel blockers. It works by relaxing the blood vessels so the heart does not have to pump as hard. Benazepril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
    [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".