NDC 0169-4136 Ozempic

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 0169-4136 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
0169-4136
Proprietary Name:
Ozempic
Product Type: [3]
Labeler Name: [5]
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]
12-06-2017
End Marketing Date: [10]
10-31-2023
Listing Expiration Date: [11]
10-31-2023
Exclude Flag: [12]
D
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Code Structure Chart

Product Details

What is NDC 0169-4136?

The NDC code 0169-4136 is assigned by the FDA to the product Ozempic which is product labeled by Novo Nordisk. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0169-4136-02 2 syringe, plastic in 1 carton / 1.5 ml in 1 syringe, plastic (0169-4136-11). 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.

Which are Ozempic UNII Codes?

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

Which are Ozempic 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 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]

* 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

[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, 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".