Ustekinumab-aauz Injection, Solution
Product Images NDC 65219-862

Product Visual Gallery

This gallery contains 26 technical images submitted to the FDA as part of the official labeling for Ustekinumab-aauz (NDC 65219-862). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Usa, Llc, 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

Ustek-img-01.jpg (Ustek Img 01)

Instructional illustration showing the Ustekinumab-AAUZ injection device before and after administration. The diagram labels key parts including the plunger, finger flange, needle, needle guard wings, needle guard activation clips, body, viewing window, and needle cover, demonstrating the needle guard release and coverage after use.*

FDA Label Image

Ustek-img-02.jpg (Ustek Img 02)

An instructional line drawing showing a hand holding an injection device with labeled needle guard wings, illustrating the correct grip on the subcutaneous injection device for USTEKINUMAB-AAUZ.*

FDA Label Image

Ustek-img-03.jpg (Ustek Img 03)

An instructional illustration showing a hand holding a prefilled syringe labeled for Ustekinumab-aauz subcutaneous injection. The image depicts the removal of the syringe cap by pulling it upward with the other hand, indicating preparation for administration.*

FDA Label Image

Ustek-img-04.jpg (Ustek Img 04)

A line graph titled 'PsA STUDY 1' showing the percentage of patients over 24 weeks across three groups: placebo, USTEKINUMAB 45 mg, and USTEKINUMAB 90 mg. The y-axis represents the percentage of patients (0-60%), and the x-axis represents time in weeks (0-24). The graph compares the patient response rates for the placebo and the two USTEKINUMAB dosage levels.*

FDA Label Image

Ustek-img-05.jpg (Ustek Img 05)

An instructional illustration showing components for subcutaneous injection preparation and disposal. It includes an adhesive bandage, antiseptic wipes, a cotton ball or gauze pads, an Otulfi prefilled syringe, and an FDA-cleared sharps disposal container.*

FDA Label Image

Ustek-img-06.jpg (Ustek Img 06)

An instructional diagram of a USTEKINUMAB-AAUZ subcutaneous injection device showing labeled parts including plunger, plunger head, needle guard activation clips, needle guard wings, body with viewing window, label, needle, and detachable needle cover.*

FDA Label Image

Ustek-img-07.jpg (Ustek Img 07)

Illustration showing recommended subcutaneous injection sites for ustekinumab-aauz solution, including the thigh, abdomen, upper arm, and buttocks areas, indicated by shaded regions on a human figure.*

FDA Label Image

Ustek-img-08.jpg (Ustek Img 08)

An instructional illustration showing a hand holding a prefilled injection device and another hand removing a small cap or cover from the device. Arrows indicate the direction of removal, suggesting preparation steps for subcutaneous injection of USTEKINUMAB-AAUZ solution.*

FDA Label Image

Ustek-img-09.jpg (Ustek Img 09)

An instructional illustration showing a person holding a prefilled syringe, demonstrating how to handle or prepare the syringe for subcutaneous injection. The hands are positioned around the syringe, with attention to the plunger and needle area.*

FDA Label Image

Ustek-img-10.jpg (Ustek Img 10)

An instructional diagram showing the technique for subcutaneous injection of USTEKINUMAB-AAUZ. It depicts a hand administering an injection at a 45-degree angle into the skin near the thigh, illustrating proper angle and site for injection.*

FDA Label Image

Ustek-img-11.jpg (Ustek Img 11)

An instructional diagram showing a hand holding a prefilled injection device. The image highlights the "Needle Guard Wings" on the device, likely demonstrating a step in the preparation or administration of a subcutaneous injection.*

FDA Label Image

Ustek-img-12.jpg (Ustek Img 12)

An illustration showing a hand holding a prefilled syringe, positioned to indicate the removal of a protective cap by pulling it upwards. The syringe is likely related to the administration of a medication by subcutaneous injection.*

FDA Label Image

Ustek-img-13.jpg (Ustek Img 13)

An instructional illustration showing recommended materials for injection preparation and disposal: adhesive bandage, antiseptic wipes, cotton ball or gauze pads, a vial labeled Otulfi, a syringe with attached needle, and an FDA-cleared sharps disposal container.*

FDA Label Image

Ustek-img-14.jpg (Ustek Img 14)

Illustration showing recommended subcutaneous injection sites for USTEKINUMAB-AAUZ. Highlighted areas include the outer thigh, the upper arm, the abdomen (avoiding the navel), and the upper buttocks. The diagram features front and back views of a human body with shaded regions indicating injection locations.*

FDA Label Image

Ustek-img-15.jpg (Ustek Img 15)

An instructional illustration showing two vials of liquid injection solution. The image indicates removing the cap from one vial by an upward arrow, demonstrating how to open it before use.*

FDA Label Image

Ustek-img-16.jpg (Ustek Img 16)

An instructional illustration showing two hands: one holding a small vial and the other removing or lifting the vial's cap by pulling it upward. The image depicts a step in preparing an injection.*

FDA Label Image

Ustek-img-17.jpg (Ustek Img 17)

An instructional line drawing showing how to remove or attach a needle to a syringe. One hand holds a syringe with a needle attached, while the other hand holds a needle cap. Arrows indicate the needle should be pulled straight off or pushed straight on.*

FDA Label Image

Ustek-img-18.jpg (Ustek Img 18)

An instructional illustration showing two hands preparing a syringe and vial for injection. One hand holds a vial upright, while the other hand inserts the needle of a syringe into the vial's rubber stopper to draw liquid medication.*

FDA Label Image

Ustek-img-19.jpg (Ustek Img 19)

An instructional illustration showing two hands preparing a subcutaneous injection. One hand holds a vial upside down while the other hand uses a syringe to draw the solution from the vial.*

FDA Label Image

Ustek-img-20.jpg (Ustek Img 20)

An instructional line drawing showing two hands preparing an injection. One hand holds a vial upside down with a needle inserted, while the other hand is pressing the plunger of a syringe. The image illustrates the process of drawing a solution into a syringe, likely for subcutaneous injection.*

FDA Label Image

Ustek-img-21.jpg (Ustek Img 21)

An instructional line drawing showing a hand administering a subcutaneous injection to the thigh of a person. The syringe is held at a 45-degree angle to the skin, demonstrating proper injection technique.*

FDA Label Image

Ustek-img-22.jpg (Ustek Img 22)

An instructional line drawing showing a hand holding a syringe used for subcutaneous injection. The syringe is positioned at an angle to the skin, indicated by a directional arrow, illustrating proper injection technique.*

FDA Label Image

Ustek-label-01.jpg (Ustek Label 01)

Carton packaging for USTEKINUMAB-AAUZ 45 mg/0.5 mL injection, solution for subcutaneous use. The label shows the drug name, strength, dosage form, single-dose prefilled syringe indication, and instructions to discard unused portion. Manufactured by Fresenius Kabi USA, LLC. Includes barcodes, lot number, expiration date area, and warnings about seal integrity and medication guide dispensing.*

FDA Label Image

Ustek-label-02.jpg (Ustek Label 02)

Label of USTEKINUMAB-AAUZ 45 mg/0.5 mL single-dose prefilled syringe for subcutaneous injection. The label includes storage instructions, manufacturer Fresenius Kabi USA, LLC, NDC 65219-862-01, lot and expiration placeholders, and warnings not to freeze or shake the product.*

FDA Label Image

Ustek-label-03.jpg (Ustek Label 03)

The image shows the packaging label for Ustekinumab-aauz 90 mg/mL injection, intended for subcutaneous use. The label includes dosage form details as a single-dose prefilled syringe with instructions to discard unused portions. It also notes the product is a sterile solution with no preservatives and is labeled by Fresenius Kabi USA, LLC, with NDC 65219-866-26.*

FDA Label Image

Ustek-label-04.jpg (Ustek Label 04)

Label for USTEKINUMAB-AAUZ 90 mg/mL injection, solution in a single-dose prefilled syringe. The label includes storage instructions (36°F to 46°F, protect from light, do not shake, do not freeze), manufacturer Fresenius Kabi USA, LLC, and usage for subcutaneous injection. Also shows an NDC number, lot, and expiration date placeholders.*

* 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.