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.

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Image 1 (UDENYCA ONBODY injector)

An illustrated diagram of a prefilled syringe for UDENYCA 6 mg solution injection. It labels key parts including the plunger rod, syringe barrel, medicine inside the barrel, a label showing lot and expiration date, and a gray needle cap at the tip.*

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Image 2 (UDENYCA ONBODY injector)

An instructional diagram showing the front and back views of a UDENYCA injection device. The front view highlights features such as the fill indicator, pull tabs, metal medicine port for filling, status light, and green fill guide. The back view notes the automatic needle opening with warnings not to fill in that area and shows adhesive backing.*

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Image 3 (UDENYCA ONBODY injector)

An instructional diagram showing preferred injection sites for a subcutaneous injection. Highlighted areas include the back of the upper arm (triceps) on both arms and the abdomen in the front torso view. The figure illustrates appropriate body locations for administering UDENYCA injection.*

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Image 4 (UDENYCA ONBODY injector)

Illustration of a medication injection device with a green lever and a yellow label marked 'FULL PUSH,' accompanied by an alcohol wipe packet. The device appears designed for subcutaneous injection, consistent with use for UDENYCA (pegfilgrastim-cbqv) 6 mg/0.6 mL injection.*

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Image 5 (UDENYCA ONBODY injector)

An instructional illustration showing two hands holding a medical device or injection system with colored tabs (green and blue). The right hand is pulling on the blue tab, indicating an action to activate or prepare the device for use.*

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Image 6 (UDENYCA ONBODY injector)

Illustration showing a hand holding a prefilled syringe, demonstrating where to grip the syringe barrel indicated by arrows and the text 'Grab here.' The syringe is positioned above a molded tray designed to hold the syringe securely.*

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Image 7 (UDENYCA ONBODY injector)

An instructional diagram showing a prefilled syringe for a subcutaneous injection. Labeled parts include the plunger rod, syringe barrel with a label showing lot and expiration date, medicine inside the barrel, and a gray needle cap on the needle end.*

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Image 8 (UDENYCA ONBODY injector)

An instructional illustration showing how to prepare a syringe for injection by removing air bubbles before administering with an on-body injector. The diagram includes a hand holding a syringe with an arrow pointing to the needle cap, accompanied by bullet-point instructions on safely removing air bubbles without recapping the syringe.*

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Image 9 (UDENYCA ONBODY injector)

An instructional illustration showing hands preparing an injection device by inserting a syringe vertically at a 90-degree angle into a green component of a medical device tray. A close-up highlights the syringe tip engaging with the component, indicating proper alignment for use.*

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Image 10 (UDENYCA ONBODY injector)

An instructional diagram showing hands using the UDENYCA injection device, with an arrow indicating to push down on the syringe plunger. Symbols below depict an 'OKAY LIGHT' and a word 'BEEPS,' indicating device activation signals during use.*

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Image 11 (UDENYCA ONBODY injector)

Illustration of the UDENYCA 6 mg/.6 mL subcutaneous injection device showing a window with a color indicator bar. The yellow label indicates when the device is FULL or EMPTY based on the position of the black bar in the indicator window.*

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Image 12 (UDENYCA ONBODY injector)

Instructional illustration showing the removal of a UDENYCA prefilled injection device from its packaging. It depicts a hand lifting the device upward from its tray, and another close-up demonstrating how to squeeze and lift a green safety clip from the device, with an indication of an "OKAY LIGHT" symbol.*

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Image 13 (UDENYCA ONBODY injector)

Instructional illustration demonstrating the removal of tabs 1 and 2 from an injection device for UDENYCA (pegfilgrastim-cbqv) 6 mg/.6mL solution. The first step shows unpeeling tab 1 with indication of an 'OKAY LIGHT.' The second step shows unpeeling tab 2, with a note about automatic needle opening, guiding proper device use.*

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Image 14 (UDENYCA ONBODY injector)

An illustration depicting a hand holding a white, rectangular injection device likely representing a subcutaneous injection pen for UDENYCA (pegfilgrastim-cbqv) 6 mg/.6 mL solution, highlighting use or handling of the product.*

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Image 15 (UDENYCA ONBODY injector)

An instructional illustration showing a hand pressing firmly on the on-body injector device attached to a person's upper arm. The accompanying text emphasizes ensuring proper adhesion by pressing around the entire adhesive, holding the top of the injector while securing the adhesive with the finger, and advises against using materials that could cover indicators or compress the device against the skin.*

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Image 16 (UDENYCA ONBODY injector)

Illustration showing a person applying UDENYCA (pegfilgrastim-cbqv) injection patch to the upper arm. The image depicts the adhesive patch placement for subcutaneous administration of the 6 mg/0.6 mL injection solution by Accord BioPharma, Inc.*

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Image 17 (UDENYCA ONBODY injector)

An illustration showing a person applying or wearing a small, square adhesive patch or device on the skin of the lower abdomen near the navel. A hand is gently touching the device, which appears to have a central label with markings. The image relates to the subcutaneous administration route for an injection solution, consistent with UDENYCA (pegfilgrastim-cbqv) medication.*

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Image 18 (UDENYCA ONBODY injector)

A text panel displaying a red stop sign icon followed by the warning message: 'Check the quality of adhesion before sending the patient home.' This warning likely relates to ensuring proper application or adhesion of a medical product to the patient.*

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Image 19 (UDENYCA ONBODY injector)

Illustration showing incorrect application of adhesive on a UDENYCA injection device. One image shows the adhesive wrinkled, and the other shows the adhesive folded, both marked with red Xs indicating mistakes to avoid.*

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Image 20 (UDENYCA ONBODY injector)

Illustration showing an incorrect condition with a medical device featuring an error light flashing red and beeping. The image highlights a flashing red error light labeled 'ERROR LIGHT' and the word 'BEEPS' in blue to indicate an audible alert. The word 'Incorrect' appears next to the device.*

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Image 21 (UDENYCA ONBODY injector)

An instructional diagram showing two illustrations of an on-body injector device with red X marks indicating incorrect conditions: one with saturated adhesive and the other with fluid dripping from the injector. The diagram advises on what to do if the adhesive becomes saturated or if the device is dripping fluid.*

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Image 1 (UDENYCA ONBODY injector)

An illustrated on-body injector device for UDENYCA (pegfilgrastim-cbqv) injection, with a yellow indicator labeled FULL and EMPTY. Adjacent text fields provide spaces to document the application day and time, expected injection start day and time, healthcare provider name and contact, and the on-body injector lot number.*

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Image 2 (UDENYCA ONBODY injector)

An instructional illustration showing a device with a status light and fill indicator. The status light has green and red states representing different conditions. The fill indicator is a yellow rectangle with black markings labeled FULL and EMPTY, showing how to read the fill level with arrows indicating positions at FULL and EMPTY.*

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Image 3 (UDENYCA ONBODY injector)

An instructional diagram showing the use of a device involving a 27-hour timer, indicated by a clock symbol and an arrow. The image depicts a green light labeled 'OKAY LIGHT' and a device applied on the skin near an ear, illustrating its position and activation status.*

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Image 4 (UDENYCA ONBODY injector)

An anatomical illustration showing the back and upper left arm of a person with a medical patch or device applied on the outer upper arm area. The illustration likely demonstrates a site for subcutaneous injection or drug delivery relevant to the product UDENYCA (pegfilgrastim-cbqv).*

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Image 5 (UDENYCA ONBODY injector)

An illustration showing the use of a UDENYCA injection device on a person's skin. It includes an 'OKAY LIGHT' symbol and a clock indicating 5 minutes, suggesting the injection site should be observed for this duration after administration.*

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Iimage 6 (UDENYCA ONBODY injector)

An instructional diagram showing on-body injector usage warnings for UDENYCA (pegfilgrastim-cbqv) injection. It highlights that the injector should not be removed if the status light is flashing green and advises checking for leaks during the 5-minute dose delivery. Two incorrect conditions are depicted: noticeably wet adhesive and dripping fluid from the on-body injector.*

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Image 7 (UDENYCA ONBODY injector)

An instructional diagram showing the correct and incorrect status light indicators on a medical device, likely an on-body injector. The correct status is indicated by a solid green 'Finish Light,' meaning the dose is complete. The incorrect status shows a flashing red 'Error Light' with accompanying beeps, indicating the injector is not functioning properly. Users are advised not to remove the device if the light is flashing green and to contact healthcare providers if the red light flashes.*

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Image 8 (UDENYCA ONBODY injector)

Illustration showing a hand peeling off the adhesive backing of a UDENYCA injection device prior to subcutaneous administration. The diagram highlights the preparation step of removing the protective adhesive cover from the injection site on the skin.*

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Image 9 (UDENYCA ONBODY injector)

An instructional image featuring a red octagonal stop sign alongside red text that reads, 'Check to see if your on-body injector is empty.' This graphic emphasizes a safety check step for users of an on-body injector device.*

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Image 10 (UDENYCA ONBODY injector)

An illustration showing a hand holding a UDENYCA prefilled injection device. The device has an indicator window with markings labeled FULL and EMPTY and a black bar that moves to show the injection status from FULL to EMPTY.*

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Image 11 (UDENYCA ONBODY injector)

A text panel providing instructions for interpreting the status light on a medical device. It explains that a solid green light or no light indicates delivery is complete, a leak requires contacting a healthcare provider immediately, and a red light signals the need to contact a healthcare provider for a possible replacement dose.*

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Image 12 (UDENYCA ONBODY injector)

An instructional illustration showing a hand disposing of a medical sharps container lid with an UDENYCA (pegfilgrastim-cbqv) injection device into a red sharps disposal container. The image emphasizes safe disposal of the injection product after use.*

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Image 13 (UDENYCA ONBODY injector)

An instructional illustration showing a close-up of an indicator window on the UDENYCA injection device. The window displays options labeled FULL and EMPTY with a blue arrow pointing to the EMPTY position, indicating the correct usage or status check of the injection device.*

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Image 14 (UDENYCA ONBODY injector)

A text panel titled 'What to do if you hear beeping or when you look at status light and it is flashing red?'. The panel provides instructions or information related to device alerts associated with the use of the product, UDENYCA (pegfilgrastim-cbqv) injection. The text is in English and is clearly displayed in red font at the top of the panel.*

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Image 15 (UDENYCA ONBODY injector)

An instructional illustration showing an infusion device with an error light indicator. The image displays a red error light illuminated and the word 'Incorrect' with a red X, accompanied by text indicating the device emits a beeping sound when the error light is on.*

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Image 16 (UDENYCA ONBODY injector)

This text panel addresses the question, "What do I do if the on-body injector comes off before the full dose is delivered?" It likely provides instructions or guidance related to the use of the UDENYCA on-body injector for subcutaneous injection.*

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Image 17 (UDENYCA ONBODY injector)

A text panel titled as a question regarding the presence of blood at the application site after removal of an on-body injector. The text is in red font on a white background, likely part of patient instructions or FAQs for using UDENYCA injection.*

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Image 18 (UDENYCA ONBODY injector)

This text panel addresses user concerns about site redness or tenderness following removal of an on-body injector device, providing guidance specific to injection site reactions.*

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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)

The image shows two rectangular boxes side by side with bold black borders. The left box contains the text 'LOT' and the right box contains the text 'SN' in uppercase letters. This likely represents designated areas on a label for lot number and serial number information typically found on pharmaceutical product packaging.*

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Image 4 (UDENYCA ONBODY injector)

UDENYCA 6 mg/.6 mL injection solution in a single-dose prefilled syringe for subcutaneous use. The label includes the proprietary name, generic name pegfilgrastim-cbqv, dosage strength, and Accor BioPharma Inc. as the labeler. The syringe and label are shown clearly with legible text.*

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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)

UDENYCA 6 mg/0.6 mL injection, solution for subcutaneous use. The product is a human prescription drug containing the active ingredient pegfilgrastim-cbqv. The packaging is labeled by Accord BioPharma, Inc.*

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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)

The image shows a warning label with a red background and white text stating "WARNING Projectile Hazard Keep outside MRI scanner room." It includes a symbol with an 'MR' inside a circle crossed by a diagonal line, indicating MRI safety warning.*

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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)

An illustration showing a medical injection syringe with a needle attached, and a separate plunger component. The image appears to depict parts of a syringe used for subcutaneous injection.*

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Image 23 (UDENYCA ONBODY injector)

The image shows a UDENYCA injection, solution for subcutaneous use, containing pegfilgrastim-cbqv at a strength of 6 mg/0.6 mL. The product is presented in a single-dose prefilled syringe with a safety needle shield, labeled by Accord BioPharma, Inc.*

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Image A (UDENYCA ONBODY injector)

A data table summarizing electromagnetic emissions testing of the delivery system, including emissions test types, frequency ranges, and compliance levels for radiated emissions per IEC 60601-1-2/CISPR 11 and ETSI EN standards, indicating compliance with Class B for home healthcare environments.*

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Image B (UDENYCA ONBODY injector)

A data table presenting the results of electromagnetic immunity testing for the delivery system of UDENYCA (pegfilgrastim-cbqv) injection. It details various immunity tests including electrostatic discharge, radiated RF EM fields, rated power frequency magnetic fields, and proximity magnetic fields, listing corresponding IEC test levels and compliance levels.*

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Image C (UDENYCA ONBODY injector)

A data table listing various radio frequency bands, their MHz ranges, associated communication services, modulation types, and immunity test levels in volts per meter (V/m). Services include TETRA, GMRS, LTE, GSM, Bluetooth, WLAN, RFID, among others, with modulation types primarily pulse modulation and FM. The table also includes a footnote on test conditions related to immunity test levels.*

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Logo (Logo)

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Image Of Udenyca Before Use (Udenyca 01)

An illustrated diagram of a syringe with labeled parts including needle cap, needle, needle safety guard unactivated, label, syringe body, inspection window, finger grips, plunger, and plunger head.*

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Image Of Udenyca After Use (Udenyca 02)

An instructional line drawing labeled 'Figure 2', depicting a syringe with an activated Needle Safety Guard. The image highlights the safety feature designed to protect against needle sticks, showing the guard engaged on the syringe.*

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Image Of Storage (instructions for use)

An instructional diagram showing a box labeled UDENYCA pegfilgrastim-cbqv with an arrow pointing to an open refrigerator, indicating the storage of the UDENYCA product in a refrigerated environment.*

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Image Of Removal From Storage (instructions for use)

An instructional diagram showing a hand holding an UDENYCA (pegfilgrastim-cbqv) carton with an arrow pointing toward a vial filling machine or similar device. The lower part of the image zooms in on an expiry date printed as 'EXP: 2019 JAN' on the carton, labeled as Figure 3.*

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Image Of Opening Udenyca (instructions for use)

An instructional illustration showing hands holding and partially opening a package labeled UDENYCA pegfilgrastim-cbqv. The image demonstrates the correct way to open or handle the product packaging for the injection solution.*

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

An illustration of a stopwatch showing 30 minutes with an arrow indicating a clockwise rotation, labeled as Figure 5. This likely represents a timing instruction or duration related to the product use or procedure.*

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Image Of Gathering Supplies (instructions for use)

An instructional illustration showing a sharps disposal container labeled 'SHARPS CONTAINER' and three related medical items: an alcohol wipe packet, a cotton ball, and an adhesive bandage. The figure is labeled as 'Figure 6.'*

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Image Of Proper Hand Washing (instructions for use)

An instructional illustration showing hands being washed with running water and soap. The image depicts the manual lathering and rinsing process as a hygiene step, likely related to preparation for medication administration or injection.*

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

Instructional illustration showing the removal of the protective cover from a UDENYCA pegfilgrastim-cbqv injection, solution prefilled syringe for subcutaneous use. The image depicts a hand holding the syringe and peeling back the cover to prepare the medication for administration.*

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Image Of Visual Inspection (instructions for use)

An instructional illustration showing a hand holding a prefilled syringe labeled with an 'Inspection Window,' highlighting the area of the syringe for visual inspection before use.*

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Image Of Injection Site Selection (instructions for use)

An anatomical illustration showing recommended injection sites for a subcutaneous injection. Marked areas include the abdomen, thigh, upper outer buttock, and back of the upper arm, indicated on front and back views of a human body.*

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Image Of Cleaning Injection Site (instructions for use)

An instructional illustration showing a hand using a square pad or wipe to clean or disinfect a circular area on a surface, likely part of a medical or injection preparation process.*

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Image Of Removal Of Needle Cap (instructions for use)

An instructional illustration depicting two steps for using an injection device. The left side shows a hand holding the device with the cap being removed upward. The right side shows a hand holding the device, with an arrow pointing upward indicating the next step, presumably preparing the injection for use.*

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Image Of Position Of Fingers (instructions for use)

An instructional illustration showing a hand holding a prefilled syringe with a needle. The image demonstrates the proper grasp and positioning for administering a subcutaneous injection using the syringe.*

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

An illustrative diagram labeled 'Figure 14' showing a hand pinching and lifting a section of skin, likely demonstrating skin preparation or injection technique for a subcutaneous injection.*

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Image Of Proper Needle Insertion (instructions for use)

An instructional illustration showing how to administer a subcutaneous injection. The image depicts a hand holding a syringe at a 45-degree angle to the skin, with a dotted line indicating a 90-degree angle for reference. The injection is given into a raised fold of skin.*

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Image Of Injection Finger Positioning (instructions for use)

An instructional illustration showing a hand holding a prefilled syringe and injecting a solution subcutaneously into the skin of another person's arm or hand. The depicted injection device is consistent with the dosage form of an injection solution for subcutaneous administration.*

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Image Of Plunger Push (instructions for use)

An instructional diagram showing the proper technique for holding and using a syringe to administer a UDENYCA (pegfilgrastim-cbqv) injection. The zoomed inset highlights details of the syringe mechanism or needle cover being manipulated.*

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Image Of Needle Retraction (instructions for use)

An instructional illustration showing hands operating a prefilled syringe for UDENYCA (pegfilgrastim-cbqv) injection, solution, subcutaneous use. The figure demonstrates the steps for removing a needle cap from the syringe, with arrows indicating the direction of movement.*

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Image Of Disposal (instructions for use)

An instructional illustration showing a hand disposing of a used prefilled syringe into a labeled sharps container. The syringe is shown in a vertical position above the container opening, indicating safe disposal of injection equipment.*

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Image Of Carton Label (principal panel)

Box packaging label for UDENYCA 6 mg/0.6 mL injection, solution for subcutaneous use, containing pegfilgrastim-cbqv. The label shows the product name prominently with dosage strength and form. It is a single-dose prefilled syringe by Accord BioPharma, Inc. The label includes product details, usage instructions for subcutaneous injection, and manufacturing information.*

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Image Of Ai Carton Label (principal panel)

UDENYCA 6 mg/0.6 mL injection solution carton label for subcutaneous use containing pegfilgrastim-cbqv. The label features green and yellow accents, the Accord BioPharma, Inc. logo, and states the product is a single-dose prefilled autoinjector. The NDC number 69448-026-63 is printed on the packaging.*

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

An instructional illustration showing a hand placing a rectangular box into a refrigerator, accompanied by a clock indicating a 30-minute duration. This image likely demonstrates the recommended refrigeration time for the product before use.*

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

An instructional illustration showing steps for handling a subcutaneous injection device. It highlights locating the expiration date on the device, discarding used materials in a waste bin, and washing hands with water from a faucet.*

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Image Of Choosing Injection Site (AI instructions for use)

An instructional illustration showing recommended injection sites for administration of a subcutaneous injection. For self or caregiver administration, the abdomen and thigh are highlighted, while for caregiver-only administration, the back of the upper arm and buttock are indicated.*

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Image Of Choosing Injection Site (AI instructions for use)

An instructional illustration showing a hand pressing a small adhesive patch or device onto the skin. This image likely demonstrates the application of a subcutaneous injection or related procedure associated with the UDENYCA injection solution.*

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Image Of Checking Veiwing Window (AI instructions for use)

An instructional illustration showing the UDENYCA injection device with a close-up of the viewing window indicating the presence of fluid inside the device prior to administration.*

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

An instructional illustration showing a hand holding a pen-like injection device, with the other hand removing or attaching a cap from the top. Green arrows indicate the direction of cap removal or attachment, demonstrating a step in preparing the injection device for use.*

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

An instructional illustration showing a hand holding a UDENYCA injection pen vertically at a 90-degree angle, likely demonstrating the correct orientation for administering the subcutaneous injection of pegfilgrastim-cbqv 6 mg/.6mL solution.*

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

An illustration showing a hand holding a UDENYCA injection pen vertically. The image includes a green downward arrow indicating a pressing motion and the text 'First "Click",' demonstrating how to activate or use the injection pen for subcutaneous administration.*

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Image Of After Second Click (AI instructions for use)

Illustration depicting proper use of the UDENYCA pegfilgrastim-cbqv injection solution pen. It shows a hand holding the pen vertically after the second click, with instructions to count to 5, emphasizing correct timing for injection completion.*

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

An instructional illustration showing a hand holding a prefilled syringe with the plunger being pulled back, indicated by a green upward arrow, as part of the injection preparation process for UDENYCA (pegfilgrastim-cbqv) 6 mg/0.6 mL, a subcutaneous injection.*

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

An instructional illustration showing a hand disposing of a syringe with needle attached into a sharps disposal container. This image relates to safe disposal practices for syringes used with injections.*

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

An instructional illustration showing parts of the UDENYCA (pegfilgrastim-cbqv) 6 mg/0.6 mL subcutaneous injection autoinjector. It details the clear cap, gray needle guard, viewing window, gray plunger, autoinjector body, and label with product name and generic name. The after-use section shows an orange indicator filling the viewing window when the injection is complete.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.