Imbruvica Capsule
Product Images NDC 57962-070

Product Visual Gallery

This gallery contains 27 technical images submitted to the FDA as part of the official labeling for Imbruvica (NDC 57962-070). 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

The Following Structure For Ibrutinib Is Kinase Inhibitor. 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 (Imbruvica 01)

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

FDA Label Image

A Graph Showing The Number Of The Number Of The Number Of The Number Of The Number Of The Number Of The Number Of The Number Of The Number Of The Number Of The Number Of The Number Ofai-generated Content May Be Incorrect. (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.*

FDA Label Image

A Graph Showing The Number Of Numbersai-generated Content May Be Incorrect. (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.*

FDA Label Image

A Graph Showing The Number Of Patientsai-generated Content May Be Incorrect. (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.*

FDA Label Image

Figure 4: Kaplan-meier Curve Of Progression-free Survival (itt Population) In Patients With Cll/sll In Helios (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.*

FDA Label Image

A Graph Showing The Number Of Patientsai-generated Content May Be Incorrect. (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.*

FDA Label Image

A Graph Showing The Number Of Objectsai-generated Content May Be Incorrect. (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.*

FDA Label Image

A Graph Showing The Growth Of A Stock Marketai-generated Content May Be Incorrect. (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

Warning (Imbruvica 09)

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.*

FDA Label Image

Figure A (Imbruvica 0a)

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

Figure B (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

Figure C (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.*

FDA Label Image

Figure D (Imbruvica 0d)

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.*

FDA Label Image

Diagramdescription Automatically Generated (Imbruvica 0e)

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.*

FDA Label Image

Diagramdescription Automatically Generated (Imbruvica 0f)

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.*

FDA Label Image

Diagramdescription Automatically Generated (Imbruvica 10)

An instructional illustration showing how to properly expel air bubbles from a syringe. It depicts a hand holding a syringe vertically and pushing the plunger to remove air, with an inset showing a comparison between a syringe with an air bubble labeled NO and one without air bubble labeled YES.*

FDA Label Image

Figure H (Imbruvica 11)

An instructional illustration showing a hand inserting a syringe into a bottle, held by another hand, with an upward arrow indicating to pull the syringe upward. This suggests a step in preparing or drawing up medication from the bottle.*

FDA Label Image

Diagramdescription Automatically Generated (Imbruvica 12)

An instructional illustration showing a person opening their mouth while another hand uses a syringe to administer medication orally. The image highlights the syringe tip being inserted into the mouth, indicating oral administration technique.*

FDA Label Image

A Picture Containing Vector Graphicsdescription Automatically Generated (Imbruvica 13)

An instructional illustration depicting a hand opening a bottle by twisting off the cap, while the other hand holds the bottle steady. No specific product branding or text is visible on the bottle label in the image.*

FDA Label Image

Diagramdescription Automatically Generated (Imbruvica 14)

An instructional illustration showing hands holding a syringe under a running faucet, depicting the process of rinsing or cleaning the syringe under water in a sink.*

FDA Label Image

Arrow (Imbruvica 15)

FDA Label Image

Ndc 57962-070-28imbruvica®(ibrutinib) Capsules70 mgeach Capsule Contains: Ibrutinib 70 mgswallow Capsules Whole With Water28 Capsulesrx Onlypharmacyclics®an Abbvie Companyjanssen (Imbruvica 16)

Imbruvica 70 mg capsules packaging label showing the proprietary name Imbruvica with the generic name Ibrutinib. The label indicates 70 mg strength and a bottle containing 28 capsules. The labeler is Pharmacyclics LLC, with marketing by Janssen Biotech, Inc. Storage directions and usage indication to follow physician dosing are present on the label.*

FDA Label Image

Ndc 57962-140-09imbruvica®(ibrutinib) Capsules140 mgeach Capsule Contains: Ibrutinib 140 mgswallow Capsules Whole With Water90 Capsulesrx Onlypharmacyclics®an Abbvie Companyjanssen (Imbruvica 17)

Packaging label for Imbruvica (ibrutinib) capsules, 140 mg strength. The label shows the product name and strength prominently, identifies the dosage form as capsules, and indicates a package size of 90 capsules. It is distributed by Pharmacyclics LLC and marketed by Janssen Biotech, Inc. The label includes storage instructions, manufacturer information, and the NDC number 57962-140-09.*

FDA Label Image

Ndc 57962-014-28imbruvica®(ibrutinib) Tablets140 mg Per Tableteach Tablet Contains Ibrutinib 140 mgwallet Card Contains 28 Tabletsrx Onlypharmacyclics®an Abbvie Companyjanssen (Imbruvica 18)

Imbruvica 140 mg film-coated tablets packaging label. The label displays the brand and generic names (Ibrutinib), tablet strength (140 mg), quantity (28 tablets), and manufacturer (Pharmacyclics LLC). It also includes directions on how to take the medication and instructions for opening the package securely.*

FDA Label Image

Ndc 57962-280-28imbruvica®(ibrutinib) Tablets280 mg Per Tableteach Tablet Contains Ibrutinib 280 mgwallet Card Contains 28 Tabletsrx Onlypharmacyclics®an Abbvie Companyjanssen (Imbruvica 19)

Imbruvica 280 mg oral tablets packaging label by Pharmacyclics LLC. The label displays the proprietary name Imbruvica with the generic name ibrutinib, strength of 280 mg per tablet, and indicates the quantity of 28 tablets. Instructions on how to take the medication are also partially visible along with tamper-evident packaging features and manufacturer information for Janssen.*

FDA Label Image

Ndc 57962-420-28imbruvica®(ibrutinib) Tablets420 mg Per Tableteach Tablet Contains Ibrutinib 420 mgwallet Card Contains 28 Tabletsrx Onlypharmacyclics®an Abbvie Companyjanssen (Imbruvica 1a)

Imbruvica 420 mg film-coated tablets packaging label showing the bottle with 28 tablets. The label includes the proprietary name Imbruvica and generic name ibrutinib, strength 420 mg per tablet, and manufacturer Pharmacyclics LLC. Directions for use, NDC code, and a blue instructional section for proper bottle opening are also visible on the label.*

FDA Label Image

Ndc 57962-007-12imbruvica®(ibrutinib)oral Suspension70 mg/mlfor Oral Use Onlyshake Well Before Each Usediscard After 60 Daysrx Only108ml Per Bottle Pharmacyclics®an Abbvie Companyjanssen (Imbruvica 1b)

Imbruvica (ibrutinib) Oral Suspension 70 mg/mL carton label. The label indicates oral use only, with instructions to shake before use and discard after 60 days. It contains one 108 mL bottle, two 3 mL oral syringes, a pre-inserted adapter, and accompanying instructions. Distributed by Pharmacyclics LLC and marketed by Janssen Biotech, Inc. Storage guidelines specify 36°F to 77°F (2°C to 25°C) and cautions against freezing.*

* 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.