NDC 0039-0221 Amaryl

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
0039-0221
Proprietary Name:
Amaryl
Product Type: [3]
Labeler Code:
0039
FDA Application Number: [6]
NDA020496
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
06-18-2009
End Marketing Date: [10]
08-31-2023
Listing Expiration Date: [11]
08-31-2023
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Patient Education

Glimepiride


Glimepiride is used along with diet and exercise, and sometimes with other medications, to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Glimepiride lowers blood sugar by causing the pancreas to produce insulin (a natural substance that is needed to break down sugar in the body) and helping the body use insulin efficiently. This medication will only help lower blood sugar in people whose bodies produce insulin naturally. Glimepiride is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may occur if high blood sugar is not treated). Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.
[Learn More]


Diabetes Medicines


What is diabetes?

Diabetes is a disease in which your blood glucose, or blood sugar, levels are too high. Glucose comes from the foods you eat. The cells of your body need glucose for energy. A hormone called insulin helps the glucose get into your cells.

With type 1 diabetes, your body does not make insulin. With type 2 diabetes,your body does not make or use insulin well. Without enough insulin, glucose can't get into your cells as quickly as usual. The glucose builds up in your blood and causes high blood sugar levels.

What are the treatments for diabetes?

Treatments for diabetes can depend on the type. Common treatments include a diabetic meal plan, regular physical activity, and medicines. Some less common treatments are weight loss surgery for either type and an artificial pancreas or pancreatic islet transplantation for some people with type 1 diabetes.

Who needs diabetes medicines?

People with type 1 diabetes need to take a diabetes medicine called insulin to control their blood sugar.

Some people with type 2 diabetes can control their blood sugar with healthy food choices and physical activity. But for others, a diabetic meal plan and physical activity are not enough. They need to take diabetes medicines.

The kind of medicine you take depends on your type of diabetes, daily schedule, medicine costs, and any other health conditions that you have. Over time, you may need to take more than one diabetes medicine.

What are the types of medicines for type 1 diabetes?

If you have type 1 diabetes, you must take insulin because your body no longer makes it. There are different types of insulin that start to work at different speeds, and the effects of each last a different length of time. Your health care provider will measure your blood glucose to decide on the type of insulin. You may need to use more than one type.

You will also need to check your blood sugar at home. Your provider will tell you how often. The results of your blood sugar testing can help you make decisions about food, physical activity, and medicines.

You can take insulin several different ways. The most common are with a needle and syringe, an insulin pen, or an insulin pump. If you use a needle and syringe or a pen, you have to take insulin several times during the day, including with meals. An insulin pump gives you small, steady doses throughout the day. Less common ways to take insulin include inhalers, injection ports, and jet injectors.

In rare cases, taking insulin alone might not be enough to manage your blood sugar. Then you would need to take another diabetes medicine.

What are the types of medicines for type 2 diabetes?

There are several different medicines for type 2 diabetes. Each works in a different way. Many of them are pills. There are also medicines that you inject under your skin, such as insulin.

Over time, you may need more than one diabetes medicine to manage your blood sugar. You might add another diabetes medicine or switch to a combination medicine. A combination medicine contains more than one type of diabetes medicine in the same pill. Some people with type 2 diabetes take both pills and injections.

Even if you don't usually take insulin, you may need it at special times, such as during pregnancy or if you are in the hospital.

What else should I know about taking medicines for diabetes?

Even if you take medicines for diabetes, you still need to eat a healthy diet, stop smoking, take your other medicines, and get regular physical activity. These will help you manage your diabetes.

It is important to make sure that you understand your diabetes treatment plan. Talk to your provider about:

  • What your target blood sugar level is
  • What to do if your blood sugar gets too low or too high
  • Whether your diabetes medicines will affect other medicines you take
  • If you will have any side effects from the diabetes medicines

You should not change or stop your diabetes medicines on your own. Talk to your provider first.

NIH: National Institute of Diabetes and Digestive and Kidney Diseases


[Learn More]


* Please review the disclaimer below.

Product Footnotes

[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.

[10] 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.

[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".