NDC 0069-2260 Caduet

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

Product Information

NDC Product Code:
0069-2260
Proprietary Name:
Caduet
Non-Proprietary Name: [1]
Amlodipine Besylate And Atorvastatin Calcium
Substance Name: [2]
Amlodipine Besylate; Atorvastatin Calcium Trihydrate
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 Name: [5]
    Pfizer Laboratories Div Pfizer Inc
    Labeler Code:
    0069
    FDA Application Number: [6]
    NDA021540
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    01-30-2004
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    ROUND (C48348)
    OVAL (C48345)
    Size(s):
    6 MM
    8 MM
    10 MM
    9 MM
    11 MM
    14 MM
    17 MM
    Imprint(s):
    PFIZER;CDT;251
    PFIZER;CDT;252
    PFIZER;CDT;254
    PFIZER;CDT;051
    PFIZER;CDT;052
    PFIZER;CDT;054
    PFIZER;CDT;058
    Score:
    1

    Product Packages

    NDC Code 0069-2260-30

    Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $19.15101 per EA

    Product Details

    What is NDC 0069-2260?

    The NDC code 0069-2260 is assigned by the FDA to the product Caduet which is a human prescription drug product labeled by Pfizer Laboratories Div Pfizer Inc. The generic name of Caduet is amlodipine besylate and atorvastatin calcium. 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 0069-2260-30 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 Caduet?

    This product contains 2 medications: amlodipine and atorvastatin. Amlodipine is a calcium channel blocker and is used to treat high blood pressure or prevent chest pain (angina). It works by relaxing the blood vessels so that blood can flow more easily and the heart does not need to work so hard. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Preventing chest pain can help improve your ability to exercise. Atorvastatin is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

    What are Caduet 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 5 mg/1 - A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.
    • ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 - A pyrrole and heptanoic acid derivative, HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITOR (statin), and ANTICHOLESTEREMIC AGENT that is used to reduce serum levels of LDL-CHOLESTEROL; APOLIPOPROTEIN B; and TRIGLYCERIDES. It is used to increase serum levels of HDL-CHOLESTEROL in the treatment of HYPERLIPIDEMIAS, and for the prevention of CARDIOVASCULAR DISEASES in patients with multiple risk factors.

    Which are Caduet UNII Codes?

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

    Which are Caduet 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 Caduet?

    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: 404011 - amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral Tablet
    • RxCUI: 404011 - amlodipine 5 MG / atorvastatin 80 MG Oral Tablet
    • RxCUI: 404011 - amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet
    • RxCUI: 404013 - amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral Tablet
    • RxCUI: 404013 - amlodipine 10 MG / atorvastatin 80 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]


    Atorvastatin


    Atorvastatin is used together with diet, weight loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Atorvastatin is also used to decrease the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol ('bad cholesterol') and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol ('good cholesterol') in the blood. Atorvastatin may also be used to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 10 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Atorvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats with atorvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.
    [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".