Imuldosa Injection
Product Images NDC 69448-017

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Imuldosa (NDC 69448-017). 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.

FDA Label Image

Carton Label (130 mg 26 mL Carton)

Packaging label for IMULDOSA (ustekinumab-srlf) Injection, 130 mg/26 mL (5 mg/mL), by Accord BioPharma Inc. The label indicates it is a single-dose vial for intravenous infusion only, must be diluted, and should be stored refrigerated. Manufacturer details include Accord BioPharma Inc. and Catalent Indiana, LLC, with product origin Republic of Korea.*

FDA Label Image

130mg/ml (130 mg 26 mL Label)

Label for IMULDOSA (ustekinumab-srlf) Injection, 130 mg/26 mL (5 mg/mL) by Accord BioPharma Inc. The label indicates this is for intravenous infusion only, must be diluted, sold in a single-dose vial, and includes storage instructions to refrigerate between 2°C to 8°C (36°F to 46°F). The label includes barcode, NDC 69448-019-26, and manufacturer details.*

FDA Label Image

Blister Label (45 mg 05 mL Blister)

Label for IMULDOSA (ustekinumab-srlf) Injection, 45 mg/0.5 mL subcutaneous single-dose prefilled syringe. The label includes storage instructions to refrigerate at 36°F to 46°F, manufacturer information for Accord BioPharma Inc. (Raleigh, NC, USA) and Accord Healthcare Ltd. (Newcastle Upon Tyne, UK), and a barcode. The label features the Accord BioPharma logo and a purple, orange, and white color scheme.*

FDA Label Image

Carton Label (45 mg 05 mL Carton)

Packaging label for IMULDOSA (ustekinumab-srlf) Injection, 45 mg/0.5 mL, for subcutaneous use. The label displays dosage strength prominently in a purple box and states it is a single-dose prefilled syringe. Manufactured by Accord BioPharma Inc., the label includes storage instructions, usage indications, and warnings, along with branding and barcodes.*

FDA Label Image

Pfs Label (45 mg 05 mL Label)

Label for IMULDOSA 45 mg/0.5 mL injection, a single-dose prefilled syringe of ustekinumab-srlf for subcutaneous use. The label includes storage instructions, manufacturer Accord BioPharma Inc., barcode, lot number, and expiration date.*

FDA Label Image

Blister Label (90 mg 1 mL Blister)

Label for IMULDOSA (ustekinumab-srlf) Injection, 90 mg/mL, a subcutaneous human prescription drug. The label indicates a single-dose prefilled syringe, with storage instructions to refrigerate at 36ºF to 46ºF (2ºC to 8ºC) and warnings to protect from light, not to shake or freeze, and to keep out of reach of children. Manufactured by Accord BioPharma Inc. and Accord Healthcare Ltd.*

FDA Label Image

Carton Label (90 mg 1 mL Carton)

Packaging label for IMULDOSA 90 mg/mL injection, containing ustekinumab-srlf for subcutaneous use. The label includes the drug name, strength, dosage form, storage instructions, and prescribing information note. It is labeled Rx only and manufactured by Accord BioPharma Inc. The packaging also features barcodes and a product identifier NDC 69448-018-63.*

FDA Label Image

Syringe Label (90 mg 1 mL Label)

Label for IMULDOSA 90 mg/mL single-dose prefilled syringe injection containing ustekinumab-srlf. The label states it is for subcutaneous use only and provides storage instructions to keep between 36°F to 46°F (2°C to 8°C), protected from light, and not to shake or freeze. It is labeled with Rx only, lot number, expiration date, and manufactured by Accord BioPharma Inc.*

FDA Label Image

Figure A (Imuldosa 01)

An illustrated instruction diagram showing components included with IMULDOSA injection: an adhesive bandage, antiseptic wipes, a cotton ball or gauze pads, an IMULDOSA prefilled syringe, and an FDA-cleared sharps disposal container. These items are depicted in a row, each labeled with its name.*

FDA Label Image

Figure B (Imuldosa 02)

Illustration diagram of a subcutaneous injection device for IMULDOSA (ustekinumab-srlf), showing labeled parts including plunger head, plunger, needle guard wings, needle guard activation clips, safety guard spring, body with label, extended finger flanges, needle, and needle cover.*

FDA Label Image

Figure C (Imuldosa 03)

Illustration showing recommended subcutaneous injection sites for IMULDOSA (ustekinumab-srlf). Shaded areas indicate possible injection locations on the upper thigh, upper arm, lower abdomen, and buttocks of a human figure.*

FDA Label Image

Figure D (Imuldosa 04)

An instructional illustration showing two hands manipulating a syringe and a needle cap, demonstrating the process of removing the needle cap from the syringe, likely related to the preparation of a subcutaneous injection.*

FDA Label Image

Figure E (Imuldosa 05)

An instructional illustration showing a hand holding a syringe for subcutaneous injection, indicating the injection site on the skin with a dotted line and arrow. The image demonstrates the proper technique for administering a subcutaneous injection.*

FDA Label Image

Figure F (Imuldosa 06)

An instructional illustration showing how to administer a subcutaneous injection using a syringe at a 45-degree angle into the skin on the knee area. One hand holds the syringe while the other hand stabilizes the injection site.*

FDA Label Image

Figure G (Imuldosa 07)

An instructional illustration showing a hand holding a syringe, highlighting the needle guard wings. The diagram focuses on the needle guard mechanism, indicating its position relative to the user's thumb and fingers for safe needle handling.*

FDA Label Image

Figure H (Imuldosa 08)

An instructional line drawing showing a hand holding a syringe preparing for a subcutaneous injection. The illustration emphasizes the gripping technique and direction for administering the injection using a syringe.*

FDA Label Image

Figure 1 (Figure 1)

Line graph titled 'PsA STUDY 1' showing the percentage of patients on the y-axis and weeks on the x-axis over a 24-week period. The graph compares placebo (n=206), ustekinumab 45 mg (n=205), and ustekinumab 90 mg (n=204). Both ustekinumab doses show increasing patient percentages over time, with the 90 mg dose reaching the highest percentages compared to placebo.*

FDA Label Image

Needle Wings (Needle Guard Wings)

An instructional illustration showing a hand holding a syringe with emphasis on the 'needle guard wings' feature, which is indicated by a labeled arrow. The drawing highlights the part of the syringe designed to protect or shield the needle for safety during use.*

FDA Label Image

Plunger Head (Plunger Head)

An instructional line drawing showing a hand holding a syringe with the thumb pushing the plunger, indicating the motion of injection. The illustration suggests subcutaneous injection technique, relevant to IMULDOSA, ustekinumab-srlf injection.*

FDA Label Image

Syringe (Syringe Label)

An instructional diagram showing the labeled components of a subcutaneous injection device for IMULDOSA (ustekinumab-srlf), including the plunger head, plunger, needle guard wings, needle guard activation clips, safety guard spring, body, label, extended finger flanges, needle, and needle cover.*

* 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.