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  4. NDC Product Code: 72241-002 Nateglinide

NDC 72241-002 Nateglinide

Tablet, Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 72241-002?
  5. Nateglinide 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

NDC Product Code:
72241-002
Proprietary Name:
Nateglinide
Non-Proprietary Name: [1]
Nateglinide
Substance Name: [2]
Nateglinide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Modavar Pharmaceuticals Llc
    Labeler Code:
    72241
    Product Label ID:
    af81465b-5f49-4eeb-8122-ef7fe5d90ddc
    FDA Application Number: [6]
    ANDA206432
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    08-19-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328)
    Shape:
    ROUND (C48348)
    Size(s):
    9 MM
    Imprint(s):
    C123
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 72241-002?

    The NDC code 72241-002 is assigned by the FDA to the product Nateglinide which is a human prescription drug product labeled by Modavar Pharmaceuticals Llc. The product's dosage form is tablet, coated and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 72241-002-04 90 tablet, coated in 1 bottle , 72241-002-05 100 tablet, 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 Nateglinide?

    Nateglinide is used alone or with other medications to control high blood sugar along with a proper diet and exercise program. It is used in people with type 2 diabetes. 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. It works by stimulating the body to produce more insulin. Insulin is a natural substance that allows the body to properly use sugar from the diet.

    What are Nateglinide 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.
    • NATEGLINIDE 60 mg/1 - A phenylalanine and cyclohexane derivative that acts as a hypoglycemic agent by stimulating the release of insulin from the pancreas. It is used in the treatment of TYPE 2 DIABETES.

    Which are Nateglinide UNII Codes?

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

    Which are Nateglinide 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 Nateglinide?

    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 for Nateglinide?

    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 disclaimer below.

    Patient Education

    Nateglinide


    Nateglinide is used alone or in combination 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) in people whose diabetes cannot be controlled by diet and exercise alone. Nateglinide belongs to a class of drugs called meglitinides. Nateglinide helps your body regulate the amount of glucose (sugar) in your blood. It decreases the amount of glucose by stimulating the pancreas to release insulin. 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]


    Bupropion


    Bupropion (Aplenzin, Wellbutrin, Wellbutrin SR, Wellbutrin XL) is used to treat depression. Bupropion (Aplenzin, Wellbutrin XL) is also used to treat seasonal affective disorder (SAD; episodes of depression that occur at the same time each year [usually in the fall and winter but rarely may occur in the spring or summer months]). Bupropion (Zyban) is used to help people stop smoking. Bupropion is in a class of medications called antidepressants. It works by increasing certain types of activity in the brain.
    [Learn More]


    Antidepressants


    What are antidepressants?

    Antidepressants are prescription medicines to treat depression. Depression is more than feeling a little sad or "blue" for a few days. It's a very common, serious medical illness that affects your mood and general mental health It can make you feel tired, hopeless, worried, or fearful. It can change your thinking, sleeping, and eating. Depression may make some people think about ending their lives.

    But antidepressants can help many people who have depression. Researchers think antidepressants may help improve the way your brain uses certain chemicals that control mood or stress.

    Are antidepressants used for other conditions?

    A health care provider may prescribe antidepressants for anxiety, chronic pain, or insomnia. Sometimes providers also prescribe antidepressants for other conditions.

    What are the different types of antidepressants?

    There are many types of antidepressants. Each one works differently. Providers usually prescribe newer antidepressants first because they don't cause as many side effects as older types. They also seem to help more kinds of depression and anxiety problems.

    Most of the newer antidepressants belong to one of these three groups:

    • Selective serotonin reuptake inhibitors (SSRIs)
    • Serotonin and norepinephrine reuptake inhibitors (SNRIs)
    • Atypical antidepressants, which are newer antidepressants that don't fit into the other groups

    If these antidepressants don't help, your provider might suggest one of the older antidepressants. The older types include tricyclic antidepressants (TCAs), tetracyclics, and monoamine oxidase inhibitors (MAOIs). Even though these antidepressants may cause more serious side effects, the benefits may outweigh the risks for some people.

    Which type of antidepressant is right for me?

    Our bodies and brains all work differently. That means one antidepressant won't work for everyone. You may need to try two or more medicines before you find one that works for you.

    Your provider will work with you to choose the best option to try first. You'll consider questions such as:

    • Which symptoms bother you most? Some antidepressants may do a better job helping specific symptoms, such as trouble sleeping.
    • What other medicines and supplements do you take? Some antidepressants can cause problems if you take them with certain medicines and herbs.
    • Did a certain antidepressant work well for a close relative? An antidepressant that helped a parent, brother, or sister could be a good choice for you, too.
    • Do you have other health conditions? Certain antidepressants can make some other conditions better or worse. Any other conditions that you have will be part of choosing your depression treatment.
    • Are you pregnant, planning for pregnancy, or breastfeeding? If so, your provider will help you find a way to treat your depression that's safe for you and your baby.

    How long do antidepressants take to work?

    Antidepressants usually take 4 to 8 weeks to work, so you'll need to be patient. You may notice that some problems, such as sleeping and eating, get better before your mood improves. That's a good sign. You may just need to give the medicine a little more time to do its job.

    Sometimes an antidepressant helps at first, but symptoms return while you're still taking it. But there's usually another one you can try. To get more relief from depression, your provider may suggest combining two antidepressants, using another kind of medicine with an antidepressant, or adding talk therapy or other approaches to improve your mental health.

    How long will I need to take an antidepressant?

    When an antidepressant starts to work, you and your provider can decide how long you need to stay on it. The typical length of treatment is 6 to 12 months, but some people may stay on antidepressants for much longer.

    What are the side effects of antidepressants?

    Not everyone has side effects from antidepressants. But if you do have them, they're usually mild and may get better over time as your body gets used to the new medicine.

    The most common side effects from antidepressants include:

    When thinking about side effects, it's important to remember that there are also risks from not treating depression. Your provider can help you think through the pros and cons of all your options.

    If you have any side effects from antidepressants, your provider may suggest ways to manage them while you wait to see if the antidepressant will work. If the side effects bother you too much, you may need to change antidepressants. But you should never change your dose or stop taking an antidepressant on your own.

    If you have serious problems or notice any changes that worry you, such as new or worsening symptoms, unusual changes in your mood, or you start acting differently, call your provider right away.

    In some cases, children, teenagers, and young adults under 25 may be more likely to think about hurting or killing themselves when starting antidepressants or when the dose is changed. Get medical help right away if this happens.

    What can I do to take antidepressants safely?

    Antidepressants are generally safe when you use them correctly:

    • Tell your provider about everything you take. That includes medicines, herbs, supplements, and over-the-counter medicines you take, such as pain relievers and decongestants. Be honest about recreational drugs and alcohol, too.
    • Try to get all your medicines from the same pharmacy. That way the pharmacist can warn you and your provider if you take medicines that may cause problems when used together.
    • Follow all instructions about how to take your medicine.
    • Talk with your provider if side effects bother you.
    • Never stop taking antidepressants without your provider's help. Stopping too fast may make depression come back. You could even make your condition worse. To stop antidepressants safely, you need to give your body time to get used to being without the medicine. Your provider can tell you the safest way to go off an antidepressant.

    NIH: National Institute of Mental Health


    [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".