Otulfi Injection, Solution
Product Images NDC 65219-822
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Otulfi (NDC 65219-822). 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.
Product Images & Figures Index
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Principal Display Panel – 45 mg Carton Label (Otu00 0001 13)
This text contains information about ustekinumab-aauz, an injection for subcutaneous use, stored in a refrigerator between 36°F to 46°F. It comes in a single-dose prefilled syringe that should be discarded after use. The active ingredient is 45 mg/0.5 mL of ustekinumab-aauz. It also provides details on inactive ingredients and instructions on storage and handling. For dosage information, please refer to the prescribing information.*
Principal Display Panel – 45 mg Syringe Label (Otu00 0001 14)
This is a single-dose prefilled syringe with the National Drug Code (NDC) 65219-824-01. It is advised to discard any unused portion and store the syringe at 36°F to 46°F (2°C to 8°C), away from light, and without shaking. Freezing is not recommended. This syringe is for subcutaneous use. The syringe also includes information on lot number and expiry date.*
Principal Display Panel – 90 mg Carton Label (Otu00 0001 15)
This text is a detailed description of ustekinumab-aauz, an injection for subcutaneous use. It includes information on dosage, storage, manufacturer, and disposal of the single-dose prefilled syringe. The text also contains details about the active and inactive ingredients in the medication, as well as guidance on reporting side effects and contacting a doctor for medical advice.*
Principal Display Panel – 90 mg Syringe Label (Otu00 0001 16)
Single dose prefilled syringe with NDC 65219-826-26 is designed for subcutaneous use. The syringe should be stored at a cold temperature range of 36°F to 46°F to maintain its integrity. Users are advised to protect the injection from light and avoid shaking the syringe before use. The lot number and expiration date are mentioned on the packaging for reference.*
Principal Display Panel – 130 mg Carton Label (Otu00 0001 17)
This is the detailed information about a medication with the NDC 65219-828-05. It is an intravenous infusion solution containing 130 mg of ustekinumab-aauz per 26 mL vial. The solution must be diluted before use and stored in a refrigerator at 36°F to 46°F. The medication includes both active and inactive ingredients. It is a sterile solution without preservatives. Patients should consult their doctor for medical advice and report any side effects to the FDA. The medication guide should be dispensed to each patient, and any unused portion should be discarded.*
Principal Display Panel – 130 mg Vial Label (Otu00 0001 18)
This is a product label for a medical injection, specifically a single-dose vial of 130 mg/26 mL solution for intravenous infusion only. The medication should be stored in a refrigerator at 36°F to 46°F (2°C to 8°C), in the original carton, and protected from light. It is manufactured by Fresenius Kabi USA, LLC and is a product of the Netherlands. The dosage information should be obtained from the prescribing information. Unused portions of the medication should be discarded.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.