Aucatzyl Kit
Product Images NDC 83047-410

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Aucatzyl (NDC 83047-410). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Autolus 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

Figure 1 (Aucatzyl 01)

Figure 1 (Aucatzyl 01)
This is a bone marrow assessment procedure and treatment schedule document. It may include details on how to evaluate bone marrow condition and the recommended treatment plan.*
FDA Label Image

Figure 2 (Aucatzyl 02)

Figure 2 (Aucatzyl 02)
This is a list of patient specific identifiers including ApheresisID, Chain Of Identity ID, Patient Hospital ID, Patient Name, and Patient Date of Birth. These identifiers can be used to keep track of individual patients within a healthcare system.*
FDA Label Image

Image (Aucatzyl 03)

FDA Label Image

Image (Aucatzyl 04)

FDA Label Image

Image (Aucatzyl 05)

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Image (Aucatzyl 06)

Image (Aucatzyl 06)
This is a warning advising not to use the syringe for mixing cells.*
FDA Label Image

Image (Aucatzyl 07)

Image (Aucatzyl 07)
This text appears to be instructions for drawing only a specific volume of a substance as specified in the release for infusion certificate. This likely pertains to a medical or laboratory procedure where precise measurements are crucial.*
FDA Label Image

Principal Display Panel (10 mL Infusion Bag Label)

Principal Display Panel (10 mL Infusion Bag Label)
This is a description of a 10 x 106 bag configuration for the autologous and intravenous use of obecabtagene autoleucel (AUCATZYL). The product contains up to 100x106 CD19 CAR-positive viable T cells in a 10mL suspension with 7.5% DMSO USP. It is important to follow the prescribing information and release for infusion certificate and to discard any unused portion. The storage guidelines advise against the use of LEUKODEPLETING FILTER or irradiation and recommend shipping and storing in the vapor phase of liquid nitrogen below -150°C. This product has not been evaluated for infectious substances and is for prescription use only.*
FDA Label Image

Principal Display Panel (10 mL to 20 mL Infusion Bag Label)

Principal Display Panel (10 mL to 20 mL Infusion Bag Label)
This is a configuration for a bag containing 100x10° CD19 CAR-positive viable T cells in 10mL to 20mL suspension with 7.5% DMSO USP. It is for autologous and intravenous use only. The dosage information is available in the prescribing information and the release for infusion certificate. The dose can be suspended in one or more infusion bags. It is important not to store it with a leukodepleting filter or irradiate it. The product is not evaluated for infectious substances. Made by Autolus Ltd in the UK for Autolus Inc in Gaithersburg, MD. The contact number for Autolus is 1455-288-5227.*
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Principal Display Panel 30 mL To 70 mL Infusion Bag Label (100 x 10)

Principal Display Panel 30 mL To 70 mL Infusion Bag Label (100 x 10)
This text contains important information about a 100x10 bag configuration containing the medication obecabtagene autoleucel for autologous & intravenous use only. It includes details about the dosage, storage instructions, and manufacturer information. The medication consists of 100x10 CD19 CAR-positive viable T cells in a suspension containing 7.5% DMSO USP. It is crucial to follow the instructions provided in the prescribing information and infusion certificate. Storage should be done properly with specific temperature requirements to maintain product integrity. Please note that the product has not been evaluated for infectious substances. For further details or inquiries, contact Autolus Ltd or Autolus Inc using the provided contact information.*
FDA Label Image

Principal Display Panel (30 mL to 70 mL Infusion Bag Label)

Principal Display Panel (30 mL to 70 mL Infusion Bag Label)
This is a description of a medical product containing autologous CD19 CAR-positive T cells for intravenous use. The bag configuration includes 300x10 viable T cells in a suspension with DMSO USP. The dosage information must be reviewed before administration. It is important to properly handle and store the product at ultra-low temperatures. The product is not evaluated for infectious substances and is intended for autologous use only. For more details, refer to the prescribing information and the infusion certificate.*
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Principal Display Panel (Patient Information Label)

Principal Display Panel (Patient Information Label)
Not available.*
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Principal Display Panel (Kit Label)

Principal Display Panel (Kit Label)
This text appears to be information about a medication called obecabtagene autoleucel, which is intended for autologous and intravenous use only. It provides details about the dosage, shipping and storage requirements, expiration date, and manufacturer information. It is essential to follow the prescribing information and handling instructions carefully when using this medication.*

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