Glyburide Tablet
NDC 68382-656

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68382-656?
  5. Glyburide 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

Glyburide is a ANDA-approved product labeled by Zydus Pharmaceuticals (usa) Inc.. Glyburide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It is supplied as a white tablet for oral administration. This product entry covers the primary NDC 68382-656 and 6 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
68382-656
Proprietary Name:
Glyburide
Non-Proprietary Name: [1]
Glyburide
Substance Name: [2]
Glyburide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Zydus Pharmaceuticals (usa) Inc.
Labeler Code:
68382
Product Label ID:
87781ea8-62ec-483c-a4dd-8c965ce59485
FDA Application Number: [6]
ANDA206749
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
06-02-2016
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
656
Score:
2

Code Structure Chart

Product Details

What is NDC 68382-656?

The NDC code 68382-656 is assigned by the FDA to the product Glyburide. This pharmaceutical product is labeled by Zydus Pharmaceuticals (usa) Inc. and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in 6 different package configurations. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Glyburide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It may also be used with other diabetes medications. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Glyburide belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body's natural insulin.

What are Active Ingredients of this product?

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.
  • GLYBURIDE 1.25 mg/1 - An antidiabetic sulfonylurea derivative with actions like those of chlorpropamide

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the full disclaimer at the bottom of this page.

Patient Education

Glyburide


Glyburide 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). Glyburide is in a class of medications called sulfonylureas. Glyburide 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. Glyburide 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.
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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


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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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 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".