Tofacitinib Solution
Product Images NDC 70095-008

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 70095-008). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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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Fig 1 (Fig 1)

A forest plot chart showing pharmacokinetic ratios and 90% confidence intervals for various groups and conditions relative to a reference. Variables include weight (40 kg, 140 kg), age (80 years), gender (female), race (Asian, Black, Hispanic), and degrees of renal and hepatic impairment (mild, moderate, severe). The chart displays ratios for AUC and Cmax on a horizontal scale from 0.5 to approximately 3.5.*

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Fig 2 (Fig 2)

A pharmacokinetic (PK) graph displaying the ratio and 90% confidence intervals of various coadministered drugs relative to a reference. It includes data for methotrexate, midazolam (CYP3A substrate), levonorgestrel and ethinyl estradiol (oral contraceptives), and metformin (OCT & MATE substrate), showing AUC and Cmax measurements plotted along a ratio scale from approximately 0.25 to 2.0.*

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Fig 3 (Fig 3)

A scatter plot chart showing the pharmacokinetic interaction ratios and 90% confidence intervals for various coadministered drugs with Tofacitinib. The x-axis represents the ratio relative to reference (0 to 2.5), and the y-axis lists drugs including ketoconazole (CYP3A inhibitor), fluconazole (CYP3A & CYP2C19 inhibitor), rifampin (CYP inducer), methotrexate, tacrolimus, and cyclosporine, each with AUC and Cmax values depicted.*

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Fig 5 (Fig 5)

A line graph comparing response rates (%) over a 3-month period between Tofacitinib 5 mg twice daily (BID) and placebo. The x-axis represents time in months, and the y-axis represents response rate percentages. The graph shows increasing response rates for both groups, with Tofacitinib having higher rates throughout.*

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Fig 7 (Fig 7)

A line graph comparing the occurrence of disease flares (%) over time from week 18 to week 44 between two groups: Tofacitinib 5 mg BID and placebo. The vertical axis represents the percentage of disease flares, while the horizontal axis shows the weeks. Tofacitinib shows a lower percentage of flares compared to placebo, with a reported p-value of 0.0007 at week 44.*

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Ifu 1 (Ifu 1)

Illustration showing the components of a Tofacitinib oral solution dosing set, including a bottle with a screw cap, a press-in bottle adapter with ribbed end, and an oral dosing syringe labeled with parts such as barrel and plunger.*

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Ifu 10 (Ifu 10)

An instructional illustration showing Step 9 for using Tofacitinib oral solution. The image depicts a person taking the measured dose of the oral solution from a syringe by placing it in their mouth, with an arrow indicating the direction of administration.*

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Ifu 12 (Ifu 12)

Illustration showing Step 11 of cleaning an oral dosing syringe by rinsing it under running water, with arrows indicating movement directions for cleaning.*

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Ifu 2 (Ifu 2)

An instructional illustration showing Step 1 for handling the product: removing a bottle from a carton. It depicts hands opening the carton flaps and lifting the bottle out of the box, demonstrating the first step in accessing the oral solution medication.*

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Ifu 3 (Ifu 3)

An instructional illustration showing a hand opening a child-resistant bottle cap by pressing down and turning the cap to the side, labeled as Step 2 for opening the bottle.*

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Ifu 4 (Ifu 4)

Illustration showing Step 3 in a process labeled 'Insert press-in bottle adapter.' The left side depicts a hand holding a bottle, and the right side shows hands placing a press-in adapter onto the bottle's mouth, guiding correct attachment.*

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Ifu 5 (Ifu 5)

Instructional illustration showing a hand holding an oral dosing syringe with an arrow pointing upward from the syringe's plunger, indicating the step to remove air from the syringe before dosing.*

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Ifu 6 (Ifu 6)

An instructional illustration showing Step 5, which involves inserting an oral dosing syringe into a bottle held by a hand. A downward arrow indicates the motion of inserting the syringe into the bottle. This diagram is part of usage directions for Tofacitinib oral solution.*

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Ifu 7 (Ifu 7)

An instructional illustration showing the step of withdrawing a dose from a bottle using a syringe. The image depicts a hand holding a bottle upside down and another hand drawing liquid into the syringe, labeled as Step 6 in a dosing procedure.*

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Ifu 8 (Ifu 8)

An instructional illustration showing Step 7 of administering Tofacitinib oral solution. It depicts a hand holding a bottle while an oral dosing syringe is being removed straight upward from the bottle's opening.*

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Ifu 9 (Ifu 9)

An instructional illustration labeled Step 8 showing a hand holding an oral solution dosing syringe with a close-up inset highlighting the correct dose marking on the syringe barrel.*

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Ifu11 (Ifu11)

An instructional diagram illustrating Step 10 for a medication bottle: closing the bottle after withdrawing a dose. It shows a hand placing the cap on the bottle, then closing the bottle and sealing its container. The images appear to guide the oral solution's handling and storage process.*

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Carton Label (Carton Label)

Label for Tofacitinib Oral Solution 1 mg/mL, an oral solution prescription medication. The label indicates a 240 mL bottle with accompanying oral dosing syringe and press-in bottle adapter. Manufactured by Ohm Laboratories Inc. and distributed by Sun Pharmaceutical Industries, Inc. Storage instructions and medication guide information are included, with the NDC 70095-008-02.*

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Chem Stru (Chemical Stru)

Chemical structure of tofacitinib citrate, the active ingredient in Tofacitinib oral solution 1 mg/mL by Sun Pharmaceutical Industries, Inc. The diagram depicts the molecular arrangement and bonds of tofacitinib and its citrate salt form.*

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Container Label (Container Label)

Label for Tofacitinib Oral Solution 1 mg/mL, a human prescription drug in oral solution form. The label shows a 240 mL container, manufactured by Ohm Laboratories, Inc. and distributed by Sun Pharmaceutical Industries, Inc. It includes storage instructions, dosage syringe guidance, and medication guide dispensing information. The NDC number 70095-008-01 is visible along with two barcode representations.*

* 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.