NDC 0006-0277 Januvia

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

Product Information

NDC Product Code:
0006-0277
Proprietary Name:
Januvia
Non-Proprietary Name: [1]
Sitagliptin
Substance Name: [2]
Sitagliptin Phosphate
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 Code:
    0006
    FDA Application Number: [6]
    NDA021995
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    10-16-2006
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328 - PINK)
    BROWN (C48332 - LIGHT BEIGE)
    BROWN (C48332 - BEIGE)
    Shape:
    ROUND (C48348)
    Size(s):
    6 MM
    8 MM
    10 MM
    Imprint(s):
    221
    112
    277
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 0006-0277?

    The NDC code 0006-0277 is assigned by the FDA to the product Januvia which is a human prescription drug product labeled by Merck Sharp & Dohme Llc. The generic name of Januvia is sitagliptin. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 9 packages with assigned NDC codes 0006-0277-02 30 tablet, film coated in 1 dose pack , 0006-0277-14 2 blister pack in 1 carton / 7 tablet, film coated in 1 blister pack, 0006-0277-27 4 blister pack in 1 carton / 7 tablet, film coated in 1 blister pack, 0006-0277-28 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack (0006-0277-01), 0006-0277-30 30 tablet, film coated in 1 bottle , 0006-0277-31 30 tablet, film coated in 1 bottle , 0006-0277-33 30 tablet, film coated in 1 dose pack , 0006-0277-54 90 tablet, film coated in 1 bottle , 0006-0277-82 1000 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 Januvia?

    Sitagliptin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. 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. Sitagliptin is a diabetes drug that works by increasing levels of natural substances called incretins. Incretins help to control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar your liver makes.

    What are Januvia 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.
    • SITAGLIPTIN PHOSPHATE 100 mg/1 - A pyrazine-derived DIPEPTIDYL-PEPTIDASE IV INHIBITOR and HYPOGLYCEMIC AGENT that increases the levels of the INCRETIN hormones GLUCAGON-LIKE PEPTIDE-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is used in the treatment of TYPE 2 DIABETES.

    Which are Januvia UNII Codes?

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

    Which are Januvia 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 Januvia?

    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 Januvia?

    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

    Sitagliptin


    Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in adults with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Sitagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amounts of certain natural substances that lower blood sugar when it is high. Sitagliptin 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). 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

    [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".