Stelara Solution
Product Images NDC 57894-054

Product Visual Gallery

This gallery contains 25 technical images submitted to the FDA as part of the official labeling for Stelara (NDC 57894-054). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Janssen Biotech, 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 (Stelara 01)

An annotated diagram of a prefilled syringe showing its parts, including the plunger head, plunger, needle guard activation clips, needle guard wings, body, viewing window with an expiration date label, needle, and needle cover. The syringe is designed for subcutaneous injection.*

FDA Label Image

Image (Stelara 02)

An instructional illustration showing a person handling a prefilled syringe, presumably preparing to remove or secure the needle cap. The image focuses on the hands and the syringe, emphasizing safe and proper technique for injection preparation.*

FDA Label Image

Image (Stelara 03)

An instructional illustration showing a hand removing the cap from a prefilled syringe pen device, presumably for subcutaneous injection. The image highlights finger positioning and removal of a protective cap from the injection pen, which is consistent with usage instructions for STELARA (ustekinumab) injection solution.*

FDA Label Image

Figure 1 (Stelara 04)

A line graph depicting patient response percentages over 24 weeks comparing placebo, STELARA 45 mg, and STELARA 90 mg. The x-axis shows time in weeks, and the y-axis shows the percentage of patients. The legend identifies placebo with circles, STELARA 45 mg with triangles, and STELARA 90 mg with squares.*

FDA Label Image

Figure A (Stelara 05)

An instructional illustration depicting five items used for subcutaneous injection with STELARA (ustekinumab). From left to right: adhesive bandage, antiseptic wipes, cotton ball or gauze pads, a STELARA prefilled syringe, and an FDA-cleared sharps disposal container.*

FDA Label Image

Figure B (Stelara 06)

An exploded line diagram of a STELARA (ustekinumab) subcutaneous injection syringe showing labeled parts including the plunger head, plunger, needle guard activation clips, needle guard wings, body, viewing window with label showing expiration date, needle, and needle cover, illustrating the components of the single-use injection device.*

FDA Label Image

Figure C (Stelara 07)

Illustration showing recommended subcutaneous injection sites for the medication on the thigh, abdomen, upper arm, and buttocks. The areas are shaded to indicate appropriate locations for administering the injection.*

FDA Label Image

Figure D (Stelara 08)

An instructional illustration showing one hand holding a syringe with the needle pointing to the right and the other hand holding a needle cap. Arrows indicate the action of removing the needle cap from the syringe before use.*

FDA Label Image

Figure E (Stelara 09)

A black and white line illustration showing a hand holding a syringe filled with medication, with the thumb pressing the plunger, depicting the technique for subcutaneous injection of STELARA (ustekinumab) solution.*

FDA Label Image

Figure F (Stelara 10)

An instructional diagram showing the proper technique for administering a subcutaneous injection with a syringe at a 45-degree angle, illustrated on a person's thigh. The image demonstrates hand positioning and needle insertion angle.*

FDA Label Image

Figure G (Stelara 11)

An instructional diagram showing a close-up view of a hands holding a STELARA (ustekinumab) prefilled syringe. The illustration highlights the needle guard wings, demonstrating proper handling of the subcutaneous injection device.*

FDA Label Image

Figure H (Stelara 12)

An instructional illustration showing hands holding a pre-filled injection device with a visible internal spring mechanism. One hand is pushing on a release mechanism at the top, with an upward arrow indicating the direction to activate or unlock the device, suggesting preparation for subcutaneous administration of the medication.*

FDA Label Image

Figure A (Stelara 13)

An illustration showing four items related to the administration of STELARA injection. It includes an adhesive bandage, antiseptic wipes, a cotton ball or gauze pad, a vial labeled STELARA, a syringe with an attached needle, and a sharps disposal container labeled for FDA-cleared sharps disposal.*

FDA Label Image

Figure B (Stelara 14)

An instructional diagram showing recommended subcutaneous injection sites for STELARA injection solution. The highlighted areas include the front and outer thigh, the upper arm (outer area), the abdomen (except for a 2-inch area around the navel), and the upper buttocks.*

FDA Label Image

Figure C (Stelara 15)

An instructional diagram illustrating the removal of a flip-off cap from the top of a vial, showing the vial with the cap partially lifted off.*

FDA Label Image

Figure D (Stelara 16)

An instructional line drawing showing two hands opening a vial by lifting the cap. The vial appears to be a medication container, illustrating how to remove the cap prior to use.*

FDA Label Image

Figure E (Stelara 17)

An instructional line drawing showing the proper technique for removing a needle cap from a syringe. One hand holds the syringe barrel while the other hand grips the needle cap, with arrows indicating a back-and-forth motion to detach the cap.*

FDA Label Image

Figure F (Stelara 18)

An instructional illustration showing one hand holding a vial and the other hand drawing liquid from the vial into a syringe, demonstrating medication preparation from a vial for injection.*

FDA Label Image

Figure G (Stelara 19)

A black-and-white instructional illustration showing two hands preparing an injection. One hand holds a vial upside down, while the other hand inserts a syringe needle into the vial, drawing liquid. The image demonstrates proper handling for preparing a subcutaneous injection.*

FDA Label Image

Figure H (Stelara 20)

An instructional illustration showing two hands preparing a syringe by withdrawing medication from a vial. One hand holds the vial upside down while the other hand pulls back the syringe plunger to draw the solution into the syringe.*

FDA Label Image

Figure I (Stelara 21)

An instructional illustration showing a hand administering a subcutaneous injection at a 45-degree angle into the thigh. The image demonstrates proper needle insertion technique for a subcutaneous injection.*

FDA Label Image

Figure J (Stelara 22)

An instructional illustration showing a hand holding a syringe for subcutaneous injection, with an arrow indicating the plunger is being pushed to deliver the medication.*

FDA Label Image

Principal Display Panel (45 mg/0.5 mL Vial Carton)

Packaging label for STELARA (ustekinumab) injection, 45 mg/0.5 mL, for subcutaneous use. The label indicates a single-dose prefilled syringe and includes manufacturer information for Janssen Biotech, Inc. It also notes the NDC 57894-060-03 and provides dosing and medication guide dispensing instructions.*

FDA Label Image

Principal Display Panel (90 mg/mL Syringe Carton)

The packaging label for STELARA (ustekinumab) Injection 90 mg/mL for subcutaneous use. The label shows it is a single-dose prefilled syringe manufactured by Janssen Biotech, Inc. It contains 90 mg/mL ustekinumab with additional inactive ingredients and includes instructions to see package insert for dosing information and dispense the enclosed Medication Guide.*

FDA Label Image

Principal Display Panel (130 mg/26 mL Vial Carton)

Packaging label for STELARA (ustekinumab) Injection, 130 mg/26 mL (5 mg/mL) for intravenous infusion only. The label states the solution must be diluted and highlights storage instructions to keep refrigerated at 2°C–8°C and protected from light. It includes manufacturer details Janssen Biotech, Inc., Horsham, PA, and notes the product is made in The Netherlands with no US standard of potency. The label also cautions dispensing the enclosed Medication Guide and marks it as prescription only.*

* 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.