NDC 0078-0489 Exforge

Amlodipine Besylate And Valsartan Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0078-0489
Proprietary Name:
Exforge
Non-Proprietary Name: [1]
Amlodipine Besylate And Valsartan
Substance Name: [2]
Amlodipine Besylate; Valsartan
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - 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.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Code:
    0078
    FDA Application Number: [6]
    NDA021990
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    06-20-2007
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - DARK YELLOW)
    YELLOW (C48330 - LIGHT YELLOW)
    Shape:
    OVAL (C48345)
    Size(s):
    14 MM
    Imprint(s):
    NVR;ECE
    NVR;UIC
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 0078-0489?

    The NDC code 0078-0489 is assigned by the FDA to the product Exforge which is a human prescription drug product labeled by Novartis Pharmaceuticals Corporation. The generic name of Exforge is amlodipine besylate and valsartan. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 0078-0489-15 30 tablet, film coated 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 Exforge?

    This product is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 2 medications: amlodipine and valsartan. They both work by relaxing blood vessels so blood can flow more easily. Amlodipine is a calcium channel blocker and valsartan is an angiotensin receptor blocker (ARB).

    What are Exforge 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.
    • AMLODIPINE BESYLATE 10 mg/1 - A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.
    • VALSARTAN 160 mg/1 - A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION.

    Which are Exforge UNII Codes?

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

    Which are Exforge 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 Exforge?

    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: 722126 - amLODIPine 10 MG / valsartan 160 MG Oral Tablet
    • RxCUI: 722126 - amlodipine 10 MG / valsartan 160 MG Oral Tablet
    • RxCUI: 722126 - amlodipine (as amlodipine besylate) 10 MG / valsartan 160 MG Oral Tablet
    • RxCUI: 722131 - amLODIPine 10 MG / valsartan 320 MG Oral Tablet
    • RxCUI: 722131 - amlodipine 10 MG / valsartan 320 MG Oral Tablet

    * Please review the disclaimer below.

    Patient Education

    Amlodipine


    Amlodipine is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years and older. It is also used to treat certain types of angina (chest pain) and coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Amlodipine is in a class of medications called calcium channel blockers. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard. It controls chest pain by increasing the supply of blood to the heart. If taken regularly, amlodipine controls chest pain, but it does not stop chest pain once it starts. Your doctor may prescribe a different medication to take when you have chest pain. 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]


    Valsartan


    Valsartan is used in adults and in children 1 year of age and older alone or in combination with other medications to treat high blood pressure. It is also used in adults to treat heart failure (condition in which the heart is unable to pump enough blood to the rest of the body) and to improve survival after a heart attack. Valsartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. 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".