Inlexzo System
Product Images NDC 57894-225

Product Visual Gallery

This gallery contains 34 technical images submitted to the FDA as part of the official labeling for Inlexzo (NDC 57894-225). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Janssen Biotech, 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

Chemical Structure (Inlexzo 01)

Chemical structure diagram of gemcitabine hydrochloride (gemcitabine HCl), the active ingredient in INLEXZO 225 mg intravesical system by Janssen Biotech, Inc. The structure includes a fluorinated sugar moiety linked to a cytosine base with an attached hydrochloride group.*

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Image (Inlexzo 02)

Illustration of the INLEXZO intravesical system showing two main components: a coiled urinary catheter and a separate green stylet. The catheter includes a tip at one end and is marked with length indicators. The green stylet features a distinctive handle at one end. A note indicates the illustration is not to scale.*

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Image (Inlexzo 03)

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Image (Inlexzo 04)

INLEXZO gemcitabine intravesical system 225 mg/1, a human prescription drug, is shown in its packaging label. The label displays dosage strength, administration route as intravesical, and is labeled by Janssen Biotech, Inc. The image includes the product name, strength, route, and labeler information prominently on the packaging.*

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Image (Inlexzo 05)

An instructional diagram showing a medical system labeled INLEXZO with details highlighting a metal wire and minitablets within the tubing. A close-up view indicates the metal wire's position and minitablets, which may appear fused. The image includes an MRI warning symbol advising to see MRI safety information.*

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Image (Inlexzo 06)

An instructional diagram showing two parts of the INLEXZO gemcitabine intravesical system: a urinary catheter with an exit port and a green stylet with a coudé tip, depth markings, and a translucent stylet hub, illustrating components for intravesical drug administration.*

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Image (Inlexzo 07)

Illustration showing two options for preparing the INLEXZO gemcitabine intravesical system. On the left, two prefilled syringes are displayed in packaging. On the right, a person is depicted squeezing liquid from a tube into a receptacle, indicating an alternative preparation method requiring two applications.*

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Image (Inlexzo 08)

An instructional illustration depicting two sequential steps: first, peeling open a foil pouch; second, removing a sealed system package. The image demonstrates how to open the packaging for the INLEXZO gemcitabine intravesical system.*

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Image (Inlexzo 09)

Illustration showing a visual inspection step for the INLEXZO gemcitabine intravesical system. It depicts an eye looking at the product packaging and the contents inside, which include a narrow tube and another elongated component, likely parts of the administration system.*

FDA Label Image

Image (Inlexzo 10)

The packaging label of INLEXZO 225 mg/1 system for intravesical administration, containing gemcitabine intravesical. The label includes the proprietary name INLEXZO prominently on the front, with product strength and route. The labeler is Janssen Biotech, Inc, and the package design features red and white colors.*

FDA Label Image

Image (Inlexzo 11)

The packaging label for INLEXZO 225 mg intravesical system by Janssen Biotech, Inc. The label displays the proprietary name INLEXZO prominently, with the generic name gemcitabine intravesical. The packaging indicates the dosage strength as 225 mg per system. The design includes usage instructions and regulatory information in a predominantly white and blue color scheme.*

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Image (Inlexzo 12)

An instructional illustration showing two steps for opening a package. The first step depicts hands peeling open a sealed pouch. The second step shows hands peeling back a secondary wrapper or covering inside the package, indicating proper opening technique.*

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Image (Inlexzo 13)

An instructional illustration showing a person putting on a single-use glove, pulling the glove over the wrist to cover the hand completely. This image is commonly used to demonstrate proper glove application techniques.*

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Image (Inlexzo 14)

An instructional two-step line drawing illustrating hands opening a small foil or plastic blister package to remove a condom-like medical device or system component, presumably part of the INLEXZO gemcitabine intravesical system packaging or administration kit.*

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Image (Inlexzo 15)

An illustration showing components of the INLEXZO intravesical system, including a labeled green stylet, a urinary catheter with measurement markings, and the INLEXZO tubing coiled in a loop.*

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Image (Inlexzo 16)

An anatomical illustration showing a catheter inserted through the urethra into the bladder. The diagram highlights the bladder, urethra, and the catheter with labeled urinary fluid returning through it, indicating the intravesical route of administration.*

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Image (Inlexzo 17)

INLEXZO 225 mg/1 intravesical system packaging label by Janssen Biotech, Inc. The label displays the product name, active ingredient gemcitabine intravesical, dosage form as system, and includes the NDC number 57894-225. The label design includes purple and yellow color blocks and a barcode.*

FDA Label Image

Image (Inlexzo 18)

INLEXZO 225 mg/1 intravesical system by Janssen Biotech, Inc. The label includes the product name prominently, strength, dosage form, and route of administration, with detailed usage and safety information printed on a white and purple carton box.*

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Image (Inlexzo 19)

INLEXZO gemcitabine intravesical 225 mg/1 system packaged in a white box with blue and green design elements. The label displays the proprietary name and strength clearly, with Janssen Biotech, Inc noted as the manufacturer on the packaging.*

FDA Label Image

Image (Inlexzo 20)

INLEXZO gemcitabine intravesical 225 mg/1 system label displaying product and manufacturer information. The label includes dosage form as a system for intravesical use, with Janssen Biotech, Inc as the labeler. The packaging features typical labeling details for this prescription drug product.*

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Image (Inlexzo 21)

An instructional diagram showing a hand holding the first syringe connected to a system, indicating the direction of liquid flow into a catheter inserted in the bladder. The image illustrates the setup for intravesical administration of medication.*

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Image (Inlexzo 22)

An instructional illustration showing a flexible tube system for intravesical administration. The image highlights a maneuver where the tube is looped, and an inset diagram shows the tip of the catheter positioned inside the bladder, indicating catheter placement or fluid instillation procedure related to the INLEXZO gemcitabine intravesical system.*

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Image (Inlexzo 23)

Illustration showing a hand holding a syringe labeled '2nd Syringe' with a small amount of liquid being administered into a urinary catheter, depicting intravesical drug delivery technique.*

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Image (Inlexzo 24)

Illustration showing proper technique for attaching a system syringe to a connector. It includes a close-up detail with check and cross marks indicating correct and incorrect connection positions, respectively, with a hand holding the connector and a directional arrow.*

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Image (Inlexzo 25)

INLEXZO 225 mg intravesical system packaging label showing Janssen Biotech, Inc as the labeler. The label includes the proprietary name, strength 225 mg, and the dosage form as an intravesical system. The product NDC 57894-225 is displayed on the packaging.*

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Image (Inlexzo 26)

An instructional illustration showing a catheter inserted into the urethra for intravesical administration. The image highlights the catheter tip with a magnified inset focusing on the catheter balloon, indicating proper placement within the bladder for drug delivery.*

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Image (Inlexzo 27)

An illustration showing a hand holding a small rectangular card with horizontal gray lines and a yellow triangle symbol on it, likely depicting a step or component for using a medical system device.*

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Image (Inlexzo 28)

Illustration depicting the intravesical administration route of INLEXZO gemcitabine intravesical 225 mg/1 system. The diagram shows a catheter inserted through the urethra into the bladder with an arrow indicating the flow direction of the medication delivery into the bladder.*

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Image (Inlexzo 29)

Instructional illustration showing correct and incorrect ways to connect or arrange tubing for a system. The top image shows a properly connected or looped tube marked with a green check, while the bottom image shows an incorrect connection or kinked tube marked with a red X. This visual guide indicates the proper setup for safe and effective system use.*

FDA Label Image

Image (Inlexzo 30)

The image shows the packaging label for INLEXZO 225 mg/1 system, containing gemcitabine intravesical. The label indicates it is a human prescription drug manufactured by Janssen Biotech, Inc. The packaging is predominantly blue and white with detailed dosing and preparation information visible.*

FDA Label Image

Image (Inlexzo 31)

INLEXZO 225 mg/1 system label for gemcitabine intravesical administration. The white label features black text including the product name, dosage strength, and administration route. The label also displays the Janssen Biotech, Inc. name and logo, along with regulatory text and barcodes consistent with pharmaceutical packaging.*

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Image (Inlexzo 32)

An instructional illustration shows a gloved hand holding a medical device system vertically with an upward arrow indicating movement direction. A circular inset displays an incorrect method of handling the device connector, marked with a red X.*

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Image (Inlexzo 33)

INLEXZO gemcitabine intravesical system 225 mg/1 label from Janssen Biotech, Inc. The label prominently displays the proprietary name INLEXZO and the generic name gemcitabine intravesical, along with the strength of 225 mg per system. The label includes NDC 57894-225 and details about route and usage as intravesical administration.*

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Principal Display Panel (225 mg Intravesical System Box)

Packaging label for INLEXZO 225 mg gemcitabine intravesical system by Janssen Biotech, Inc. The carton highlights its use for intravesical administration, contains one sterile single-dose system with catheter and stylet, and includes prescribing information. The label features a pink to orange gradient background with warnings such as hazardous drug and MR conditional status. A QR code for additional product information and a barcode are also visible.*

* 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.