NDC 0169-4772 Ozempic

Semaglutide Injection, Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0169-4772
Proprietary Name:
Ozempic
Non-Proprietary Name: [1]
Semaglutide
Substance Name: [2]
Semaglutide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Novo Nordisk
    Labeler Code:
    0169
    FDA Application Number: [6]
    NDA209637
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    04-25-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0169-4772-12

    Package Description: 1 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC (0169-4772-11)

    Price per Unit: $311.10705 per ML

    NDC Code 0169-4772-97

    Package Description: 1 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC (0169-4772-90)

    Product Details

    What is NDC 0169-4772?

    The NDC code 0169-4772 is assigned by the FDA to the product Ozempic which is a human prescription drug product labeled by Novo Nordisk. The generic name of Ozempic is semaglutide. The product's dosage form is injection, solution and is administered via subcutaneous form. The product is distributed in 2 packages with assigned NDC codes 0169-4772-12 1 syringe, plastic in 1 carton / 3 ml in 1 syringe, plastic (0169-4772-11), 0169-4772-97 1 syringe, plastic in 1 carton / 3 ml in 1 syringe, plastic (0169-4772-90). 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 Ozempic?

    Semaglutide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Semaglutide is also used in people with type 2 diabetes and heart disease to lower the risk of death from heart attack or stroke. Semaglutide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high blood sugar (such as after a meal) and decreasing the amount of sugar your liver makes. If you use insulin, semaglutide is not a substitute for insulin treatment.

    What are Ozempic 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.

    What is the NDC to RxNorm Crosswalk for Ozempic?

    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:
    • RxCUI: 1991306 - semaglutide 2 MG in 1.5 ML Pen Injector, 0.25 or 0.5 MG Dose
    • RxCUI: 1991306 - 0.25 MG, 0.5 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen Injector
    • RxCUI: 1991306 - semaglutide 2 MG per 1.5 ML Pen Injector, 0.25 or 0.5 MG Dose
    • RxCUI: 1991311 - OZEMPIC 2 MG in 1.5 ML Pen Injector, 0.25 or 0.5 MG Dose
    • RxCUI: 1991311 - 0.25 MG, 0.5 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]

    Which are the Pharmacologic Classes for Ozempic?

    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

    Semaglutide Injection


    Semaglutide injection (Ozempic) is used along with a diet and exercise program to control blood sugar levels in adults with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) when other medications did not control the sugar levels well enough. Semaglutide injection (Ozempic) is also used to reduce the risk of a stroke, heart attack, or death in adults who have type 2 diabetes along with heart and blood vessel disease. It 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 develop if high blood sugar is not treated). Semaglutide injection is not used instead of insulin to treat people with diabetes who need insulin. Semaglutide injection (Wegovy) is used along with an individualized low-calorie, low-fat diet and exercise program to help with weight loss in obese adults or overweight adults who may also have high blood pressure, diabetes, or high cholesterol. Semaglutide injection (Wegovy) is also used along with an individualized low-calorie, low-fat diet and exercise program to help with weight loss in obese children 12 years of age or older. Semaglutide injection is in a class of medications called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. Semaglutide injection also works by slowing the movement of food through the stomach and may decrease appetite and cause weight loss. 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. Using 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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    * 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".