Ustekinumab-ttwe Injection, Solution
Product Images NDC 82009-162

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Ustekinumab-ttwe (NDC 82009-162). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Quallent Pharmaceuticals Health 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

Image Description (130 Carton)

Packaging label for Ustekinumab-ttwe Injection, 130 mg/26 mL (5 mg/mL) solution for intravenous infusion. The label indicates the product must be diluted before use and stored in a refrigerator at 2°C to 8°C. Manufactured for Quallent Pharmaceuticals Health LLC by Samsung Bioepis Co., Ltd. The label includes dosage information, storage instructions, and lists inactive ingredients. Barcode and regulatory information are also visible.*

FDA Label Image

45mg-carton (45 Carton)

Ustekinumab-ttwe 45 mg/0.5 mL injection label for subcutaneous use by Quallent Pharmaceuticals Health LLC. The label depicts a single-dose prefilled syringe with storage instructions, manufacturer details (Samsung Bioepis Co., Ltd.), and dosage strength. It includes directions for refrigeration and disposal, emphasizing it is for prescription use only.*

FDA Label Image

90mg-carton (90 Carton)

Packaging label for Ustekinumab-ttwe injection, 90 mg/mL, a subcutaneous solution. The label shows a single-dose prefilled syringe, product strength, and usage instructions. Manufactured by Samsung Bioepis Co., Ltd. for Quallent Pharmaceuticals Health LLC. Storage instructions and ingredient details are included, along with NDC 82009-162-11.*

FDA Label Image

Figure-1 (Figure 1)

An instructional diagram showing the labeled parts of a USTEKINUMAB-TTWE injection pen. The components labeled include needle cover, needle, viewing window, label on the body, needle guard wings, plunger, and plunger head.*

FDA Label Image

Figure-2 (Figure 2)

An instructional illustration showing a close-up of hands holding and manipulating the top part of a clear injection device or syringe, likely demonstrating how to prepare or use the injection mechanism for a subcutaneous solution.*

FDA Label Image

Figure-3 (Figure 3)

An illustration showing a hand holding a prefilled syringe for subcutaneous injection. The image includes an arrow indicating the removal of the syringe cap, demonstrating proper syringe preparation technique.*

FDA Label Image

Figure-a (Figure A)

Illustration showing a Ustekinumab-ttwe prefilled syringe along with components included for administration: adhesive bandage, antiseptic wipes, cotton ball or gauze pads, and an FDA-cleared sharps disposal container.*

FDA Label Image

Figure-b (Figure B)

An instructional diagram showing the components of a USTEKINUMAB-TTWE injection syringe. Labeled parts include the needle cover, needle, viewing window, label with text 'Ustekinumab-ttwe', body of the syringe, needle guard wings, plunger, and plunger head. The syringe is designed for subcutaneous injection delivery.*

FDA Label Image

Figure-c (Figure C)

An instructional illustration showing recommended subcutaneous injection sites for USTEKINUMAB-TTWE. It highlights three areas on a body diagram: the outer upper arms, the abdomen (except a 2-inch area around the navel), and the front of the thighs and upper buttocks.*

FDA Label Image

Figure-d (Figure D)

An instructional illustration showing two hands holding a syringe with arrows indicating a back-and-forth motion, likely demonstrating how to prepare or mix the solution in the syringe before administration.*

FDA Label Image

Figure-e (Figure E)

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

FDA Label Image

Figure-f (Figure F)

An instructional illustration showing the correct technique for subcutaneous injection at a 45-degree angle. The image depicts hands holding a syringe and preparing to inject into the skin, with an angle guide marker indicating 45 degrees.*

FDA Label Image

Figure-g (Figure G)

An instructional illustration showing a hand holding a prefilled syringe with the needle guard wings indicated. The image highlights the part labeled as needle guard wings, demonstrating safe handling or preparation of the subcutaneous injection device for ustekinumab-ttwe.*

FDA Label Image

Figure-h (Figure H)

An instructional black and white line illustration showing a hand holding a syringe. The syringe is being prepared for use with the plunger being pulled back as indicated by an upward arrow. The image demonstrates proper syringe handling technique.*

FDA Label Image

Figure4 (Figure4)

A line graph titled 'PsA STUDY 1' showing the percentage of patients over a 24-week period. Three lines represent different groups: Placebo (n=206), Ustekinumab 45 mg (n=205), and Ustekinumab 90 mg (n=204). The y-axis shows the percentage of patients, and the x-axis shows weeks. Ustekinumab groups show higher patient percentages over time compared to placebo.*

* 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.