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)

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Figure 1 (Imbruvica 02)

This appears to be a graph or chart as it contains symbols such as percentages, months, and drugnames. It seems to be a comparison of two drugs - Imbruvica and Ofatumumab - based on their effectiveness after several months. Without further context or a visual of the graph/chart, it is difficult to ascertain what the data represents, what the symbols mean and how they are inter-related.*

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Figure 2 (Imbruvica 03)

The text seems to be describing a comparison between two drugs: IMBRUVICA and ofatumumab. It might include data related to the effectiveness of these drugs over a period of 18 months, as well as the number of patients being treated. However, the text is not clear, and some characters are missing or incorrect.*

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Figure 3 (Imbruvica 04)

This appears to be a graph showing the efficacy of a drug called IMBRUVICA compared to the drug chlorambucil over a period of 27 months. The y-axis represents the percentage of patients who were progression-free survival (PFS) and the x-axis represents the number of months. The graph displays a significant difference between the two drugs, as indicated by the p-value calculated. However, there is no information about what condition the drugs were being used to treat.*

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Figure 4 (Imbruvica 05)

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Figure 5 (Imbruvica 06)

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Figure 6 (Imbruvica 07)

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Figure 7 (Imbruvica 08)

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Principal Display Panel (28 Capsule Bottle Carton)

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Principal Display Panel (28 Capsule Bottle Label)

Imbruvica (ibrutinib) is a medication provided in capsule form with 140mg dosage. Its indication, proper use, and precautionary measures are not available from the given text.*

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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)

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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)

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Principal Display Panel (90 Capsule Bottle Carton)

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Principal Display Panel (120 Capsule Bottle Carton)

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Principal Display Panel (28 Tablet Blister Carton)

Imbruvica* (ibrutinib) tablets are a medication used to treat certain types of cancer, including mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenstrom's Macroglobulinemia.*

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