Udenyca Injection, Solution
Product Images NDC 69448-026

Product Visual Gallery

This gallery contains 100 technical images submitted to the FDA as part of the official labeling for Udenyca (NDC 69448-026). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Biopharma, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Image 1 (UDENYCA ONBODY injector)

This text provides information about a syringe kit, including a gray needle cap, plunger rod, and a label with details such as medicine expiration date.*

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Image 2 (UDENYCA ONBODY injector)

This text describes a medical device with automatic needle opening, a fill indicator, adhesive backing, metal components, a medicine port, a status light, and a fill guide for proper filling. The device appears to have a front and back view for ease of use and maintenance.*

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Image 3 (UDENYCA ONBODY injector)

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Image 4 (UDENYCA ONBODY injector)

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Image 5 (UDENYCA ONBODY injector)

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Image 6 (UDENYCA ONBODY injector)

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Image 7 (UDENYCA ONBODY injector)

This is a description of a syringe set including a gray needle cap, syringe barrel, plunger rod, and a label indicating the medicine and expiration date.*

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Image 8 (UDENYCA ONBODY injector)

This text provides instructions on how to prevent air bubbles from interfering with the delivery of a full dose when using an on-body injector. The steps include removing the needle cap, tapping the syringe to move air bubbles to the top, pushing the air out slowly without expelling medicine, and accepting a small droplet at the needle's tip during the air purging process. It also advises against recapping the syringe. These guidelines aim to ensure proper usage and effectiveness of the on-body injector.*

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Image 9 (UDENYCA ONBODY injector)

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Image 10 (UDENYCA ONBODY injector)

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Image 11 (UDENYCA ONBODY injector)

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Image 12 (UDENYCA ONBODY injector)

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Image 13 (UDENYCA ONBODY injector)

This is a product or feature description for an "Automatic needle opening" mechanism or functionality, possibly related to a device or machine called "OKAY LIGHT." The feature seems to indicate that the needle in this device can open automatically.*

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Image 14 (UDENYCA ONBODY injector)

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Image 15 (UDENYCA ONBODY injector)

This text provides instructions on how to properly secure an on-body injector to a patient's skin. It emphasizes the importance of pressing firmly to ensure proper adhesion and advises against using materials that could obstruct audio/visual indicators or compress the injector against the skin. It also recommends pressing around the adhesive to smooth out any folds or wrinkles for a secure attachment.*

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Image 16 (UDENYCA ONBODY injector)

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Image 17 (UDENYCA ONBODY injector)

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Image 18 (UDENYCA ONBODY injector)

Check the quality of adhesion before sending the patient home.*

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Image 19 (UDENYCA ONBODY injector)

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Image 20 (UDENYCA ONBODY injector)

This text provides guidance on what to do in a situation where you hear beeping or observe a flashing red status light. It suggests that there may be an issue or alert that requires action.*

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Image 21 (UDENYCA ONBODY injector)

This text provides guidance on what to do if the adhesive of the on-body injector becomes saturated with fluid or if it starts dripping.*

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Image 1 (UDENYCA ONBODY injector)

This is a form documenting the application of an on-body injector which delivers medication. It includes spaces to record the date and time of application, as well as the contact information of the healthcare provider administering the injection. Additionally, there is a field to note the lot number of the on-body injector for tracking purposes.*

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Image 2 (UDENYCA ONBODY injector)

This is a description of a "Parts and Signals Status Light" used to indicate the status of various components or signals. It could be a visual indicator to show if certain parts are working properly or if certain signals are being sent/received.*

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Image 3 (UDENYCA ONBODY injector)

Not available.*

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Image 4 (UDENYCA ONBODY injector)

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Image 5 (UDENYCA ONBODY injector)

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Iimage 6 (UDENYCA ONBODY injector)

This is a warning and instruction related to an on-body injector device, advising not to remove it if the status light is flashing green. It also emphasizes the importance of checking the injector for leaks during the 5-minute dose delivery and having a caregiver available if the device is placed on the back of the arm. Additionally, there is a mention of the need to monitor for dripping fluid or wetness around the adhesive area of the injector.*

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Image 7 (UDENYCA ONBODY injector)

This text provides instructions for checking the status light of an on-body injector. It explains that a continuous light indicates the dose is complete, while a flashing green light means the dose is still in progress. If the status light is flashing red and the injector is beeping, this indicates a malfunction, and immediate replacement or assistance from a healthcare provider is needed.*

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Image 8 (UDENYCA ONBODY injector)

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Image 9 (UDENYCA ONBODY injector)

Check to see if your on-body injector is empty.*

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Image 10 (UDENYCA ONBODY injector)

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Image 11 (UDENYCA ONBODY injector)

This is a set of instructions related to a medical device. The text mentions different status lights and what each color indicates. A solid green light or a switched off status light indicates a completed delivery. If the on-body injector leaks, it is advised to contact your healthcare provider immediately for a potential replacement dose. A red status light also prompts you to call your healthcare provider promptly as it could signal a need for a replacement dose.*

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Image 12 (UDENYCA ONBODY injector)

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Image 13 (UDENYCA ONBODY injector)

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Image 14 (UDENYCA ONBODY injector)

This is a troubleshooting guide for dealing with beeping sounds or a flashing red status light on a device. It likely provides steps to identify the issue and instructions on how to resolve it.*

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Image 15 (UDENYCA ONBODY injector)

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Image 16 (UDENYCA ONBODY injector)

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Image 17 (UDENYCA ONBODY injector)

This text discusses a common concern related to the use of on-body injectors, such as the presence of blood at the application site after the device has been removed. It may provide information on possible causes and what actions should be taken in such a situation.*

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Image 18 (UDENYCA ONBODY injector)

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Image 1 (UDENYCA ONBODY injector)

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Image 2 (UDENYCA ONBODY injector)

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Image 3 (UDENYCA ONBODY injector)

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Image 4 (UDENYCA ONBODY injector)

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Image 4 (UDENYCA ONBODY injector)

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Image 6 (UDENYCA ONBODY injector)

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Image 7 (UDENYCA ONBODY injector)

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Image 8 (UDENYCA ONBODY injector)

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Image 9 (UDENYCA ONBODY injector)

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Image 10 (UDENYCA ONBODY injector)

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Image 11 (UDENYCA ONBODY injector)

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Image 12 (UDENYCA ONBODY injector)

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Image 13 (UDENYCA ONBODY injector)

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Image 14 (UDENYCA ONBODY injector)

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Image 15 (UDENYCA ONBODY injector)

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Image 16 (UDENYCA ONBODY injector)

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Image 17 (UDENYCA ONBODY injector)

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Image 18 (UDENYCA ONBODY injector)

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Image 19 (UDENYCA ONBODY injector)

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Image 20 (UDENYCA ONBODY injector)

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Image 21 (UDENYCA ONBODY injector)

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Image 22 (UDENYCA ONBODY injector)

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Image 23 (UDENYCA ONBODY injector)

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Image A (UDENYCA ONBODY injector)

The text provides information on the testing of the delivery system for Electromagnetic Emissions. The emissions test levels and compliance levels for radiated emission per frequency range are specified according to standards such as IEC 60601-1-2/ CISPR 11 for 30 - 1000 MHz Class B in a home healthcare environment and ETSI EN 301 489-1, ETSI EN 30 - 6000 MHz for Healthcare Environment 301489-17 and EN 55032. This data indicates that the delivery system has undergone testing to ensure compliance with electromagnetic emission standards for use in healthcare and home environments.*

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Image B (UDENYCA ONBODY injector)

The tested delivery system has undergone Electromagnetic Immunity testing for various parameters such as Electrostatic discharge (ESD), Radiated RF EM fields, magnetic fields, and proximity magnetic fields as per IEC standards. The compliance levels for each test parameter are provided in the text. The system has been assessed for factors like contact discharge, air discharge, radiated fields from 80 MHz to 2.7 GHz, and magnetic fields at different frequencies. Additionally, it has been evaluated for proximity magnetic fields at various amplitudes and frequencies as specified in IEC 61000-4 standards.*

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Image C (UDENYCA ONBODY injector)

This text provides information on the frequency, test band service, modulation, and immunity levels for various radio communication bands. It includes details such as the test levels in v/m for different frequencies under specific modulation types like pulse modulation, FM, and sine wave. Additionally, it mentions the equipment testing distance requirements for achieving immunity levels according to the IEC 61000-4-3 standards.*

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Logo (Logo)

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Image Of Udenyca Before Use (Udenyca 01)

This is a illustration showing different parts of a syringe, including the Inspection Window, Needle Cap Label, Plunger, Plunger Head, Needle Safety Guard, Syringe Finger Grips, and Body. It can be used as a reference for assembling or identifying the components of a syringe.*

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Image Of Udenyca After Use (Udenyca 02)

This text indicates an image or diagram labeled as "Needle Safety Guard Activated" and possibly showing Figure 2. It suggests the presence of a safety feature for needles in a medical or laboratory setting.*

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Image Of Storage (instructions for use)

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Image Of Removal From Storage (instructions for use)

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Image Of Opening Udenyca (instructions for use)

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Image Of Time To Reach Room Temp (instructions for use)

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Image Of Gathering Supplies (instructions for use)

This text provides a concise description of a container used for disposing of sharps, such as needles and syringes. It is a useful tool for safely discarding medical waste to prevent injuries and infections.*

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Image Of Proper Hand Washing (instructions for use)

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Image Of Removal Of Udenyca From Tray (instructions of use)

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Image Of Visual Inspection (instructions for use)

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Image Of Injection Site Selection (instructions for use)

This text appears to be a reference to the anatomy of the human body, specifically identifying areas such as the back of the upper arm, abdomen, upper outer buttock, and thigh. It seems to be a part of a diagram or informational material related to body parts and their locations.*

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Image Of Cleaning Injection Site (instructions for use)

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Image Of Removal Of Needle Cap (instructions for use)

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Image Of Position Of Fingers (instructions for use)

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Image Of Pinching Skin Of Injection Site (instructions for use)

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Image Of Proper Needle Insertion (instructions for use)

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Image Of Injection Finger Positioning (instructions for use)

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Image Of Plunger Push (instructions for use)

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Image Of Needle Retraction (instructions for use)

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Image Of Disposal (instructions for use)

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Image Of Carton Label (principal panel)

This text appears to be a description of a syringe for subcutaneous use containing a sterile solution with no preservatives. The syringe contains Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E. coli. The product is mentioned as a single-dose prefilled syringe. Additional information includes dosage specifications and unique identification details such as the NDC number.*

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Image Of Ai Carton Label (principal panel)

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Image Of Removing Udenyca From Refrigeration (AI instructions for use)

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Image Of Udenyca Autoinjector Status, Sharps Container And Hand Washing (AI instructions for use)

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Image Of Choosing Injection Site (AI instructions for use)

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Image Of Choosing Injection Site (AI instructions for use)

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Image Of Checking Veiwing Window (AI instructions for use)

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Image Of Of Removing The Cap Of The Autoinjector (AI instructions for use)

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Image Of Of How To Properly Hold The Autoinjector (AI instructions for use)

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Image Of Press And First Click (AI instructions of use)

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Image Of After Second Click (AI instructions for use)

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Image Of Proper Pull Away Of Udenyca Autoinjector Post Injection (AI instructions for use)

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Image Of Disposal Of Used Udenyca Autoinjector (AI instructions for use)

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Image Of Before Use And After Use (AI instructions for use)

This text appears to be a guide or manual for a medical device or syringe. It provides instructions on parts of the device, such as the cap, needle guard, viewing window, needle, plunger, expiration label, and orange indicator. It also gives guidance on how to recognize when the injection is complete by ensuring the orange indicator completely fills the viewing window.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.