Aucatzyl Kit
Product Images NDC 83047-410

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)

A treatment schedule diagram outlining procedures from day -13 to day 12 relative to dosing. It shows bone marrow assessment from day -13 to day -10, followed by FLU + CY treatment from day -9 to day -7 and FLU alone on day -6 and -5. Dose 1 is administered on day 1, and Dose 2 on day 10, with some days shaded to indicate timing flexibility of plus or minus 2 days.*

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Figure 2 (Aucatzyl 02)

Illustration of a cellular therapy kit bag labeled with patient-specific identifiers including Apheresis ID, Chain of Identity ID, Patient Hospital ID, Patient Name, and Patient Date of Birth. The bag features tubing connectors and a verification panel for patient ID confirmation, consistent with AUCATZYL (Obecabtagene autoleucel) cellular therapy packaging components.*

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Image (Aucatzyl 03)

FDA Label Image

Image (Aucatzyl 04)

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Image (Aucatzyl 05)

An instructional illustration showing a hand holding a syringe connected via tubing to a fluid bag. The diagram likely depicts the process of drawing or administering the cellular therapy product from the bag into the syringe.*

FDA Label Image

Image (Aucatzyl 06)

An instructional illustration showing a hand holding a syringe below a connected bag. The image includes a caution symbol and text stating "DO NOT USE THE SYRINGE TO MIX CELLS," with arrows indicating an up-and-down motion of the syringe. This diagram is likely part of handling instructions for the AUCATZYL cellular therapy kit.*

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Image (Aucatzyl 07)

An instructional illustration showing a hand holding a syringe attached to a bag with tubing. A warning label advises to draw only the volume specified in the release for infusion certificate. This diagram likely relates to the preparation or administration process of a cellular therapy product.*

FDA Label Image

Principal Display Panel (10 mL Infusion Bag Label)

Label for AUCATZYL (obecabtagene autoleucel) cellular therapy kit by Autolus Inc. The label specifies 10x10^6 bag configuration for autologous intravenous use, including dosing and storage instructions. It includes warnings about not using a leukodepleting filter or irradiation, and states storage in vapor phase liquid nitrogen at or below -150°C. Manufacturer and contact information are also shown.*

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

Label for AUCATZYL (obecabtagene autoleucel) cellular therapy kit by Autolus Inc. Displays dosage form as kit, with dose configuration of 100 x 10^6 bag. Includes storage instructions for vapor phase of liquid nitrogen at -150°C or below and a warning against using a leukodepleting filter or irradiation. Shows manufacturer and contact information along with a barcode and US license number.*

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Principal Display Panel 30 mL To 70 mL Infusion Bag Label (100 x 10)

Packaging label for AUCATZYL (obecabtagene autoleucel) 100x10⁶ bag configuration cellular therapy kit by Autolus Inc. The label includes usage instructions for autologous and intravenous use, dosage reference, cell concentration, storage conditions with vapor phase liquid nitrogen at or below -150°C, and handling warnings about not using a leukodepleting filter or irradiating. It shows the manufacturer and contact information along with a barcode and NDC*

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

Label for AUCATZYL (Obecabtagene autoleucel) 300x10^6 bag configuration cellular therapy kit by Autolus Inc. The label includes dosage instructions referencing prescribing info, specifies contents of 300x10^6 CD19 CAR-positive viable T cells in suspension with DMSO, and storage conditions of vapor phase liquid nitrogen at -150°C or below. It advises against using a leukodepleting filter or irradiating and states it is Rx only.*

FDA Label Image

Principal Display Panel (Patient Information Label)

Label for AUCATZYL (obecabtagene autoleucel) cellular therapy kit by Autolus Inc. The label includes identification information such as Aph ID, Lot/COI ID, Patient Hospital ID, patient initials, date of birth, expiry date, and serial number, along with a prominent 'VERIFY PATIENT ID' warning.*

FDA Label Image

Principal Display Panel (Kit Label)

Label for AUCATZYL (obecabtagene autoleucel) cellular therapy kit by Autolus Inc. The label includes usage instructions for autologous and intravenous use only, dose details (410 x 10^6 CD19 CAR-positive viable T cells), storage requirements in vapor phase liquid nitrogen, and handling warnings. It also shows the NDC 83047-410 barcode, lot/COI ID, Aph ID barcodes, expiration placeholder, and manufacturer contact information.*

* 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.