Xeljanz Tablet, Film Coated, Extended Release
Product Images NDC 0069-0502

Product Visual Gallery

This gallery contains 29 technical images submitted to the FDA as part of the official labeling for Xeljanz (NDC 0069-0502). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Pfizer Laboratories Div Pfizer 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.

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Chemical Structure (Xeljanz 01)

Chemical structure of tofacitinib citrate, the active ingredient in XELJANZ XR tablets. The diagram shows the molecular arrangement of tofacitinib combined with citrate components.*

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Figure 1 (Xeljanz 02)

A forest plot chart illustrating the pharmacokinetic (PK) ratios and 90% confidence intervals of tofacitinib (XELJANZ XR) related to intrinsic factors such as body weight, age, sex, race, and renal or hepatic impairment. The chart shows AUC and Cmax ratios relative to reference, with dose adjustment recommendations noted alongside for moderate to severe renal impairment and moderate hepatic impairment.*

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Figure 2 (Xeljanz 03)

A forest plot showing pharmacokinetic ratios (AUC and Cmax) and 90% confidence intervals for coadministered drugs with tofacitinib XR, including methotrexate, midazolam, levonorgestrel, ethinyl estradiol, and metformin. The plot includes dose adjustment recommendations, all stating no dose adjustment necessary.*

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Figure 3 (Xeljanz 04)

A forest plot chart showing the pharmacokinetic interaction ratios (AUC and Cmax) of XELJANZ XR (tofacitinib) when coadministered with various drugs such as Ketoconazole, Fluconazole, Rifampin, Methotrexate, Tacrolimus, and Cyclosporine. The chart includes ratio values with 90% confidence intervals and corresponding dosing recommendations.*

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Figure 4 (Xeljanz 05)

A line graph depicting response rates with standard error bars over a 6-month period comparing XELJANZ 5 mg Twice Daily and placebo. The x-axis shows time in months (0, 1, 3, 6), and the y-axis displays response rates. Two lines represent the response for XELJANZ (filled circles) and placebo (open circles), with XELJANZ showing higher response rates throughout the study duration.*

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Figure 5 (Xeljanz 06)

A line graph depicting the response rate (%) over a 3-month period for tofacitinib 5 mg BID compared to placebo. The x-axis represents visit months (0, 0.5, 1, 2, 3), and the y-axis shows response rate percentages from 0 to 100%. Two lines show increasing response rates over time, with tofacitinib demonstrating higher rates than placebo, each with standard error bars.*

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Xeljanz 06a

A line graph comparing the response rate percentage over weeks between XELJANZ 5 mg taken twice daily and a placebo. The XELJANZ 5 mg group shows a higher and increasing response rate from week 0 to week 12 before slightly declining at week 16, while the placebo group maintains a lower, gradually increasing response rate throughout the 16 weeks.*

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Figure 6 (Xeljanz 07)

A line graph comparing the occurrence of disease flare percentage over time between Tofacitinib 5 mg twice daily (N=88) and placebo (N=85). The x-axis shows weeks from 18 to 44, and the y-axis shows the occurrence of disease flare as a percentage. Both lines increase over time, with placebo showing higher percentages of disease flare than Tofacitinib, and error bars are included. A p-value of 0.0007 is noted near week 44.*

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Figure 7 (Xeljanz 08)

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Xeljanz 09

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Logo (Xeljanz 10)

An instructional diagram showing components of the XELJANZ oral liquid medication kit, including a press-in bottle adapter with ribbed end, a bottle labeled as containing XELJANZ oral solution, and an oral dosing syringe with labeled parts: barrel and plunger.*

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Logo (Xeljanz 11)

An instructional illustration showing Step 1 for product use: removing a bottle from a carton. The two-panel image depicts a hand opening the carton and lifting the bottle straight up out of the carton.*

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Image (Xeljanz 12)

Illustration showing instructions to open a medication bottle. It depicts one hand pressing down on the bottle cap while the other hand rotates the cap to open it, corresponding to a child-resistant push-and-turn cap mechanism.*

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Step 1 (Xeljanz 13)

An instructional illustration showing Step 3 of a process: inserting a press-in bottle adapter into the neck of a bottle. The image depicts hands holding the bottle and pressing the adapter firmly into place with a downward arrow indicating the action.*

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Step 2 (Xeljanz 14)

An instructional illustration depicting Step 4 for medication administration: removing air from an oral dosing syringe. The image shows a hand holding the syringe with an arrow indicating the action of expelling air from the syringe's tip.*

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Step 3 (Xeljanz 15)

An instructional illustration showing Step 5 for administering medication using an oral dosing syringe. It depicts a hand holding a medication bottle while inserting the oral dosing syringe into the bottle's opening, indicated by a downward arrow guiding the syringe insertion.*

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Step 4 (Xeljanz 16)

Instructional illustration showing Step 6 of a dosage withdrawal process: withdrawing a dose from a bottle using a syringe. The image depicts a hand holding a bottle upside down with the cap removed and another hand pulling the plunger of a syringe to draw medication from the bottle.*

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Step 5 (Xeljanz 17)

An instructional illustration showing Step 7 to remove an oral dosing syringe from a medicine container. A hand is holding the bottle steady while the syringe is being pulled upwards and removed from the bottle.*

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Step 6 (Xeljanz 18)

An instructional illustration labeled Step 8, showing a person's hand holding an oral dosing syringe with a close-up inset highlighting the medication dose line on the syringe barrel. It instructs to check the dose, emphasizing verifying the correct medication volume before administration.*

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Step 7 (Xeljanz 19)

Illustration showing a person administering an oral dose of XELJANZ XR using a syringe-like device, with the tip directed toward the open mouth, demonstrating how to take the medication.*

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Step 8 (Xeljanz 20)

Instructional illustration showing Step 10 of medication handling: closing the bottle, placing it into a carton, and closing the carton flaps. The images depict hand actions for securing the bottle cap and packaging it into the box.*

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Step 9 (Xeljanz 21)

An instructional illustration showing Step 11: cleaning an oral dosing syringe. The left side depicts drawing liquid into and expelling it from the syringe, while the right side shows rinsing the syringe under running water from a faucet.*

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Step 10 (Xeljanz 22)

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Step 11 (Xeljanz 23)

Label for Xeljanz (tofacitinib) tablets, 5 mg, extended release oral tablets. The label shows a 60-tablet supply, marked Rx only, distributed by Pfizer Labs, Division of Pfizer Inc. It includes storage instructions, barcode, and product identification details with a Pfizer logo.*

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Logo (Xeljanz 24)

Xeljanz XR (tofacitinib) extended release tablets, 11 mg strength, in a bottle of 30 tablets. The label includes storage instructions (20°C to 25°C), active ingredient details, manufacturer Pfizer Laboratories Division of Pfizer Inc, and FDA NDC 0069-0501-30. The product is prescription only.*

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Principal Display Panel (5 mg Tablet Bottle Label)

XELJANZ XR (tofacitinib) tablets packaging label showing 10 mg film-coated extended-release tablets. The label includes dosing information, storage instructions at 20°C to 25°C, a Pfizer logo, and identifiers like NDC 0069-1002-01. The package contains 60 tablets with recommended use for Ulcerative Colitis and displays expiration, lot, and serial number details.*

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Principal Display Panel (11 mg Tablet Bottle Label)

Label for XELJANZ XR (tofacitinib) extended release tablets, 22 mg strength, manufactured by Pfizer Laboratories Div Pfizer Inc. The label indicates oral film-coated tablets with a package count of 30 tablets, including storage instructions and dosage usage notes. It includes the NDC 0069-0502-30.*

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Principal Display Panel (10 mg Tablet Bottle Label)

XELJANZ XR (tofacitinib) oral solution label showing strength 1 mg/mL in a 240 mL bottle. The label includes storage instructions, dosage information, a reminder to read the medication guide, and distributor details from Pfizer Labs. The packaging emphasizes that the oral solution is prescription-only.*

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Principal Display Panel (22 mg Tablet Bottle Label)

Packaging label for Xeljanz (tofacitinib) oral solution 1 mg/mL by Pfizer. The label includes dosage form as oral solution and shows a 240 mL bottle size. Storage instructions, usage warnings, barcodes, and inclusion of an oral dosing syringe and adapter are listed. The product is Rx only and manufactured by Pfizer Laboratories.*

* 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.