Imuldosa Injection
Product Images NDC 69448-017

View Photos of Packaging, Regulatory Labels, and Product Appearance

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)

Carton Label (130 mg 26 mL Carton)
This text is likely a medication label for a single-dose vial of IMULDOSA™ (ustekinumab-self) Injection containing 130 mg of ustekinumab in 26 mL solution for intravenous infusion. It includes instructions on dosage, storage at 2°C to 8°C (36°F to 46°F), protection from light, and the composition of the solution. The vial should be discarded if the unused portion remains. The medication guide should be dispensed to each patient. The product is manufactured by Accord BioPharma Inc. in the USA and is packaged in a single-dose vial.*
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130mg/ml (130 mg 26 mL Label)

130mg/ml (130 mg 26 mL Label)
This is a product label for IMULDOSA™ (ustekinumab-self) injection containing 130 mg/26 mL. It is intended for intravenous infusion and must be diluted. The single-dose vial should be discarded if unused. Care instructions include storing the product in a refrigerator at 2°C to 8°C, keeping it in the original carton to protect from light, avoiding shaking or freezing, and keeping it out of reach of children. Aim to follow the dosage recommendations provided in the Prescribing Information.*
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Blister Label (45 mg 05 mL Blister)

Blister Label (45 mg 05 mL Blister)
This is a description for a medication called IMULDOSA™ (ustekinumab-srlf) in the form of an injection. It comes in a 45 mg/0.5 mL prefilled syringe for subcutaneous use. The instructions recommend storing it in a refrigerator between 36°F to 46°F, keeping it in the carton to protect from light, and not shaking or freezing it. The medication should be kept out of reach of children. It is manufactured by Accord BioPharmalnc in Raleigh, North Carolina, with the US License No: 2105. The text also mentions the manufacturing location at Accord Healthcare Ltd. in Newcastle Upon Tyne, United Kingdom.*
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Carton Label (45 mg 05 mL Carton)

Carton Label (45 mg 05 mL Carton)
This text contains information about a medication named "IMULDOSA" (ustekinumab-srlf) which is an injection for subcutaneous use. It comes in a single-dose prefilled syringe with 45 mg ustekinumab-srf, 2.23 mg histidine, 414 mg L-histidine hydrochloride monohydrate, 0.02 mg polysorbate 80, and 25.9 mg sucrose in a final volume of 0.5 mL. The dosage instructions are provided in the Prescribing Information. It is important to dispense the enclosed Medication Guide to each patient. The medication should be stored in a refrigerator at 36°F to 46°F (2°C to 8°C), kept in the carton to protect from light, not shaken, and not frozen to maintain its effectiveness. It is also highlighted to keep the medication out of the reach of children.*
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Pfs Label (45 mg 05 mL Label)

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Blister Label (90 mg 1 mL Blister)

Blister Label (90 mg 1 mL Blister)
This text contains information about a 90 mg/mL injection for subcutaneous use, stored in a refrigerator at 36% to 46% (2°C to 8°C). It is a single-dose prefilled syringe of ustekinumab. The syringe should be discarded if any portion remains unused. The product should be kept away from light, and should not be shaken or frozen. Manufactured by Accord BioPharma Inc., the pharmaceutical product is indicated with the NDC number 69448-018-63.*
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Carton Label (90 mg 1 mL Carton)

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Syringe Label (90 mg 1 mL Label)

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Figure A (Imuldosa 01)

Figure A (Imuldosa 01)
This text describes a Prefilled Syringe, Organ Gauge Pads for Cleared Sharps, and a Disposal Container intended for medical or laboratory use.*
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Figure B (Imuldosa 02)

Figure B (Imuldosa 02)
This text appears to describe different components related to safety in a device or equipment, including a spring, needle guard, wings, body label, needle cover, plunger, extended finger, flanges, and activation clips. The components seem to be part of a safety mechanism or system.*
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Figure C (Imuldosa 03)

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Figure D (Imuldosa 04)

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Figure E (Imuldosa 05)

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Figure F (Imuldosa 06)

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Figure G (Imuldosa 07)

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Figure H (Imuldosa 08)

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Figure 1 (Figure 1)

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Needle Wings (Needle Guard Wings)

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Plunger Head (Plunger Head)

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Syringe (Syringe Label)

Syringe (Syringe Label)
This text is a detailed description of a medical device, likely a syringe or injection device. It mentions components such as plunger, head, needle, guard, wings, activation clips, spring, body, label, cover, and flanges. The device appears to have safety features like an extended finger guard and activation clips for secure use.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.