Imbruvica Tablet, Film Coated
Product Images NDC 57962-014

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Imbruvica (NDC 57962-014). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Pharmacyclics 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.

FDA Label Image

Ibrutinib Is An Inhibitor Of Bruton’s Tyrosine Kinase (btk). It Is A White To Off-white Solid With The Empirical Formula C25h24n6o2 And A Molecular Weight 440.50. Ibrutinib Is Freely Soluble In Dimethyl Sulfoxide, Soluble In Methanol And Practically Insoluble In Water. The Chemical Name For Ibrutinib Is 1-[(3r)-3-[4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4 D]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one And Has The Following Structure: (Imbruvica 01)

Chemical structure of ibrutinib, the active ingredient in Imbruvica. The diagram depicts the molecular connections and ring structures characteristic of this compound.*

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Figure 1 (Imbruvica 02)

A Kaplan-Meier survival curve comparing progression-free survival (PFS) percentages over 15 months for Imbruvica (ibrutinib) versus ofatumumab. The graph shows higher PFS rates for Imbruvica patients, with statistical significance indicated by p<0.0001. Patient risk numbers at various time points are listed below the curves.*

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Figure 2 (Imbruvica 03)

A survival curve chart comparing overall survival (OS) percentages over months between IMBRUVICA and ofatumumab. The chart shows two lines representing OS for each treatment group from 0 to 18 months. Below the x-axis is a table displaying the number of patients at risk for each group at various time points. A p-value of less than 0.05 is indicated, suggesting statistical significance.*

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Figure 3 (Imbruvica 04)

A Kaplan-Meier survival curve comparing progression-free survival (PFS) percentages over months between Imbruvica (ibrutinib) and chlorambucil. The graph shows Imbruvica maintaining a higher PFS than chlorambucil throughout the observed period up to 27 months, with numerical data at risk displayed below the timeline.*

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Figure 4 (Imbruvica 05)

A Kaplan-Meier curve illustrating progression-free survival (%) over months comparing IMBRUVICA plus BR versus Placebo plus BR. The graph shows higher survival rates for IMBRUVICA plus BR over approximately 30 months, with subject counts at risk listed below the timeline. The chart includes a p-value of less than 0.0001 indicating statistical significance.*

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Figure 5 (Imbruvica 06)

A Kaplan-Meier plot showing progression-free survival (PFS) percentages over months for two treatment groups: Imbruvica (ibrutinib) plus obinutuzumab and chlorambucil plus obinutuzumab. The graph demonstrates higher PFS rates for the Imbruvica combination throughout the 36 months compared to the chlorambucil combination. The chart includes the number of patients at risk shown below the x-axis and a p-value indicating statistical significance.*

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Figure 6 (Imbruvica 07)

A Kaplan-Meier curve chart showing progression-free survival (PFS) percentage over time in months. It compares two treatment groups: Imbruvica plus rituximab (purple line) versus fludarabine, cyclophosphamide plus rituximab (blue dashed line). The chart includes a risk table below indicating the number of patients at risk at various time points up to 45 months.*

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Figure 7 (Imbruvica 08)

A Kaplan-Meier survival curve chart comparing progression-free survival (PFS) percentages over 60 months between two treatment groups: Ibrutinib plus Rituximab (Ibr+R) and Placebo plus Rituximab (Pbo+R). The chart shows PFS on the vertical axis and time in months on the horizontal axis. It includes median time, hazard ratio, confidence interval, and p-value statistics, with the number of patients at risk listed over time.*

FDA Label Image

Principal Display Panel (28 Capsule Bottle Carton)

Imbruvica 70 mg film-coated tablets packaging label showing drug name and strength prominently. The box includes dosage form as capsules, manufacturer details including Pharmacyclics LLC and Janssen Biotech, Inc., storage instructions, barcode, and quantity of 28 capsules. The label states oral administration and includes product identification numbers and regulatory markings.*

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Principal Display Panel (28 Capsule Bottle Label)

Imbruvica 140 mg capsules carton packaging label for oral use, containing 90 film-coated capsules of ibrutinib. The label indicates Pharmacyclics LLC as the distributor and includes storage instructions, barcodes, and authorized markings from Janssen Biotech, Inc.*

FDA Label Image

Principal Display Panel – 90 Capsule Bottle Labelndc 57962-140-09imbruvica®(ibrutinib) Capsules140 mgeach Capsule Contains: Ibrutinib 140 mgswallow Capsules Whole With Water90 Capsulesrx Onlypharmacyclics Llcan Abbvie Companyjanssen Biotech, Inc. (Imbruvica 0b)

Packaging label for Imbruvica 140 mg capsules, containing the active ingredient ibrutinib. The label indicates a quantity of 120 capsules in a film-coated tablet form, distributed and marketed by Pharmacyclics LLC with Janssen Biotech, Inc. The label includes storage instructions, barcode, and standard pharmaceutical labeling details.*

FDA Label Image

Principal Display Panel – 120 Capsule Bottle Labelndc 57962-140-12imbruvica®(ibrutinib) Capsules140 mgeach Capsule Contains: Ibrutinib 140 mgswallow Capsules Whole With Water120 Capsulesrx Onlypharmacyclics Llcan Abbvie Companyjanssen Biotech, Inc. (Imbruvica 0c)

Imbruvica 140 mg tablets packaging label for oral use contains 28 film-coated tablets. The label features the brand and generic name (ibrutinib), dosage strength, manufacturer information (Pharmacyclics LLC and Janssen), and directions on how to take the medication. The design includes instructions to open the wallet card, safety warnings, and contact information for patient support. A barcode, NDC number, and placeholders for expiration, lot, and serial numbers are also visible.*

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Principal Display Panel (90 Capsule Bottle Carton)

Imbruvica 280 mg (ibrutinib) film-coated tablets carton label for oral administration by Pharmacyclics LLC. The package contains a wallet card with 28 tablets and includes instructions on how to take Imbruvica, usage warnings, and closure instructions. The label features the Pharmacyclics and Janssen logos alongside barcodes, lot, and expiration date fields.*

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Principal Display Panel (120 Capsule Bottle Carton)

Imbruvica 420 mg oral tablets packaging carton from Pharmacyclics LLC. The box contains 28 film-coated tablets of ibrutinib. It includes instructions for use, storage info, and a push-button mechanism for opening. The label features branding logos of Pharmacyclics and Janssen, plus dosage and barcode details.*

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Principal Display Panel (28 Tablet Blister Carton)

Imbruvica 560 mg film-coated tablets packaging label by Pharmacyclics LLC. The label indicates that each tablet contains 560 mg of ibrutinib and comes in a wallet card containing 28 tablets. Instructions for use and dosage information are provided, along with a barcode and expiry details area. Janssen is also branded on the packaging.*

* 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.