Otulfi Injection, Solution
Product Images NDC 65219-826

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Otulfi (NDC 65219-826). 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

Figure (Otu00 0001 01)

An instructional diagram showing a subcutaneous injection syringe before and after administration. The labeled parts include the plunger, needle guard activation clips, needle guard wings, finger flange, body, viewing window, label, needle, and needle cover. The right side illustrates the needle guard released and covering the needle post-administration.*

FDA Label Image

Figure (Otu00 0001 02)

An instructional illustration showing a hand holding a prefilled injection device labeled with needle guard wings, demonstrating proper grip or handling technique.*

FDA Label Image

Figure (Otu00 0001 03)

An instructional illustration showing a hand holding a prefilled injection pen for a subcutaneous solution. The pen is positioned for injection, with arrows indicating the direction to remove a cap or cover before use. The image is related to the administration technique of Otulfi (ustekinumab-aauz) injection.*

FDA Label Image

Figure 1 (Otu00 0001 04)

A line graph titled 'PsA STUDY 1' showing percentage of patients on the vertical axis and weeks on the horizontal axis up to 24 weeks. The graph compares the response rates of three groups: Placebo, Ustekinumab 45 mg, and Ustekinumab 90 mg, with Ustekinumab groups showing higher patient response percentages over time than Placebo.*

FDA Label Image

Figure (Otu00 0001 05)

Illustration showing the contents of an Otulfi injection kit, including an adhesive bandage, antiseptic wipes, cotton ball or gauze pads, an Otulfi prefilled syringe, and an FDA-cleared sharps disposal container.*

FDA Label Image

Figure (Otu00 0001 06)

An instructional diagram of a prefilled syringe showing labeled parts: plunger and plunger head, needle guard activation clips and wings, body, viewing window, label, needle, and separate needle cover, illustrating the components of a subcutaneous injection device.*

FDA Label Image

Figure (Otu00 0001 07)

An instructional diagram showing possible injection sites for a subcutaneous injection. Illustrated locations include the outer thigh, the abdomen (avoiding a 2-inch area around the navel), the upper arm (back or side), and the lower back or upper buttocks.*

FDA Label Image

Figure (Otu00 0001 08)

An instructional illustration showing how to handle an injection device for Otulfi (ustekinumab-aauz). One hand holds the syringe ready for use, while the other hand holds a small cap or cover, indicating the steps for preparing the subcutaneous injection solution for administration.*

FDA Label Image

Figure (Otu00 0001 09)

An instructional line drawing showing hands holding and preparing a syringe for injection. The syringe is being manipulated by the thumb and fingers, focusing on the injection technique typically associated with subcutaneous administration.*

FDA Label Image

Figure (Otu00 0001 10)

Illustration showing a hand administering a subcutaneous injection at a 45-degree angle into the thigh area. The image depicts the proper technique for injecting using a syringe and needle.*

FDA Label Image

Figure (Otu00 0001 11)

An instructional diagram showing a hand holding a syringe with a focus on the needle and needle guard wings, demonstrating proper grip or use of the injection device.*

FDA Label Image

Figure (Otu00 0001 12)

An instructional illustration showing a hand holding a pre-filled syringe of Otulfi (ustekinumab-aauz) injection, solution. The diagram emphasizes proper finger placement and an upward arrow indicating the direction to pull or activate the syringe mechanism for subcutaneous administration.*

FDA Label Image

Principal Display Panel – 45 mg Carton Label (Otu00 0001 13)

Packaging label for Otulfi 45 mg/0.5 mL injection, solution for subcutaneous use by Fresenius Kabi USA, LLC. The carton contains one single-dose prefilled syringe. Active ingredient is ustekinumab-aauz. Storage instructions and inactive ingredients are provided on the label, along with usage warnings and manufacturer details.*

FDA Label Image

Principal Display Panel – 45 mg Syringe Label (Otu00 0001 14)

Label for Otulfi (ustekinumab-aauz) 45 mg/0.5 mL single-dose prefilled syringe injection. It is for subcutaneous use, manufactured by Fresenius Kabi USA, LLC. Storage instructions specify 36°F to 46°F (2°C to 8°C), protected from light, do not shake or freeze. Includes NDC 65219-824-01 and Rx only designation.*

FDA Label Image

Principal Display Panel – 90 mg Carton Label (Otu00 0001 15)

Packaging label for Otulfi 90 mg/mL (ustekinumab-aauz) injection, solution for subcutaneous use in a single-dose prefilled syringe. The label includes storage instructions for refrigeration, manufacturer information (Fresenius Kabi USA, LLC), and a barcode. The carton contains one prefilled syringe along with prescribing information and medication guide.*

FDA Label Image

Principal Display Panel – 90 mg Syringe Label (Otu00 0001 16)

Label for Otulfi (ustekinumab-aauz) injection, solution, 90 mg/mL in a single dose prefilled syringe. The label indicates use for subcutaneous injection, manufactured by Fresenius Kabi USA, LLC. It includes storage instructions (36°F to 46°F, protect from light, do not shake or freeze) and notes to discard unused portions. The label also shows the NDC code 65219-826-26.*

FDA Label Image

Principal Display Panel – 130 mg Carton Label (Otu00 0001 17)

Packaging label for Otulfi (ustekinumab-aauz) Injection, 130 mg/26 mL (5 mg/mL) for intravenous infusion only. The carton contains one single-dose vial and includes prescribing information and a medication guide. Manufactured by Fresenius Kabi USA, LLC. Storage instructions advise refrigeration at 36°F to 46°F (2°C to 8°C), protection from light, and no shaking or freezing.*

FDA Label Image

Principal Display Panel – 130 mg Vial Label (Otu00 0001 18)

Label for Otulfi 130 mg/26 mL (5 mg/mL) injection containing ustekinumab-aauz, manufactured by Fresenius Kabi USA, LLC. The label notes the product is for intravenous infusion only, requires dilution, and is a single-dose vial. Storage instructions specify refrigeration at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.*

* 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.