Azor
NDC 65597-112

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 65597-112?
  4. Azor Uses
  5. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Azor is a NDA-approved product labeled by Daiichi Sankyo Inc.. This product is used to treat high blood pressure (hypertension). It is supplied as a product. This product entry covers the primary NDC 65597-112 and 5 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
65597-112
Proprietary Name:
Azor
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Daiichi Sankyo Inc.
Labeler Code:
65597
FDA Application Number: [6]
NDA022100
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
09-26-2007
End Marketing Date: [10]
10-31-2023
Listing Expiration Date: [11]
10-31-2023
Exclude Flag: [12]
D

Code Structure Chart

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.
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Olmesartan


Olmesartan is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years of age and older. Olmesartan 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.
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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


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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".