Tofacitinib Solution
Product Images NDC 71085-099

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 71085-099). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ipg Pharmaceuticals, 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.

FDA Label Image

Fig 1 (Fig 1)

A scatter plot displaying pharmacokinetic ratios with 90% confidence intervals for intrinsic factors such as body weight, age, sex, race, and levels of renal and hepatic impairment. The x-axis represents the ratio relative to a reference, and the y-axis lists the factors with their associated PK parameters, AUC and Cmax.*

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Fig 2 (Fig 2)

A pharmacokinetic (PK) chart showing the ratio and 90% confidence intervals for the area under the curve (AUC) and maximum concentration (Cmax) of various coadministered drugs relative to a reference. The drugs listed include Methotrexate, Midazolam, Levonorgestrel, Ethinyl Estradiol, and Metformin, with data points plotted along a ratio scale from 0.25 to 2.*

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Fig 3 (Fig 3)

A scatter plot graph titled 'Coadministered PK Drug Ratio and 90% CI' showing ratios relative to reference for different coadministered drugs. The y-axis lists drugs including ketoconazole, fluconazole, rifampin, methotrexate, tacrolimus, and cyclosporine with parameters AUC and Cmax, while the x-axis represents the ratio values on a scale from 0 to 2.5. The graph displays 90% confidence intervals for each drug's ratio to reference.*

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Fig 5 (Fig 5)

A line graph comparing the response rate percentage over time (in months) between Tofacitinib 5 mg BID and placebo. The x-axis represents the visit month (0 to 3 months), and the y-axis shows response rate percentage (0 to 100%). Two lines are plotted: a solid line for Tofacitinib showing increasing response rates, and a dashed line for placebo with lower response rates over the same period. Error bars are included for each data point.*

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Fig 7 (Fig 7)

A line graph comparing the occurrence of disease flare as a percentage over time between Tofacitinib 5 mg BID and placebo groups. The horizontal axis represents weeks from week 18 to week 44, while the vertical axis shows the percentage of disease flare occurrence. The graph indicates lower flare rates in the Tofacitinib group compared to placebo, with statistical significance noted at p = 0.0007.*

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Ifu 1 (Ifu 1)

Illustration showing components of a Tofacitinib oral dosing kit, including a bottle with a press-in bottle adapter and a ribbed end, plus a labeled oral dosing syringe with barrel and plunger.*

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Ifu 10 (Ifu 10)

An instructional illustration showing a person taking a dose of tofacitinib oral solution by using a syringe. The image directs the syringe tip into the mouth, with an arrow indicating the delivery of the solution orally.*

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Ifu 12 (Ifu 12)

Illustration showing step 11 in a dosing instruction sequence for cleaning an oral dosing syringe. The left side depicts a hand holding a syringe with arrows indicating movement, while the right side shows the syringe being rinsed under running water from a faucet.*

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Ifu 2 (Ifu 2)

An instructional illustration showing Step 1 for a product, demonstrating removal of a bottle from a carton. The two-panel image depicts hands opening the carton flaps and lifting the bottle out vertically.*

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Ifu 3 (Ifu 3)

Illustration showing Step 2 of a medication administration process, depicting a person opening a bottle by pressing down and turning the cap. The image emphasizes the correct method to open the bottle safely.*

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Ifu 4 (Ifu 4)

Illustration showing step 3 of a medication administration guide, demonstrating how to insert a press-in bottle adapter onto a bottle. The image depicts hands holding a bottle and pressing the adapter onto the bottle's opening.*

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Ifu 5 (Ifu 5)

An instructional illustration showing a hand holding an oral dosing syringe. The image demonstrates Step 4: removing air from the syringe, indicated by an arrow pointing upwards from the syringe plunger.*

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Ifu 6 (Ifu 6)

An instructional illustration showing Step 5 in using the product: inserting an oral dosing syringe into the open neck of a small bottle held in one hand. A downward arrow indicates the syringe being inserted into the bottle opening.*

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Ifu 7 (Ifu 7)

An instructional diagram showing Step 6 for withdrawing a dose from a bottle using a syringe. The illustration depicts a hand holding a bottle upside down with another hand drawing liquid into the syringe, indicating the process of dose withdrawal from the bottle.*

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Ifu 8 (Ifu 8)

An instructional illustration showing step 7 of a procedure, which instructs to remove an oral dosing syringe from a medication bottle. The image depicts a hand holding a bottle with the syringe attached, with an upward arrow indicating the syringe removal direction.*

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Ifu 9 (Ifu 9)

An instructional illustration titled Step 8: Check the dose, showing a hand holding an oral solution syringe. A magnified view highlights the dose level indicated on the syringe's measurement markings.*

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Ifu11 (Ifu11)

An instructional illustration showing Step 10: how to close the bottle by placing a cap on it and securing it, followed by placing the bottle back into its carton packaging.*

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Carton Label (Carton Label.jpg)

Packaging label for Tofacitinib Oral Solution 1 mg/mL, an oral human prescription drug by IPG Pharmaceuticals, Inc. The label indicates a 240 mL bottle with printed dosage instructions and NDC 71085-099-24. The design features blue and red accents with safety warnings and medication guidance.*

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Chem Stru (Chemical Stru)

Chemical structure of Tofacitinib, the active ingredient in Tofacitinib oral solution 1 mg/mL by IPG Pharmaceuticals, Inc. The diagram shows the molecular arrangement including rings, nitrogen atoms, and side chains, along with a structural representation of associated components.*

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Container Label (Container Label.jpg)

Label for Tofacitinib Oral Solution 1 mg/mL, a prescription drug manufactured by IPG Pharmaceuticals, Inc. The 240 mL solution is indicated by the text and includes storage instructions, dosage guidance, and a barcode. The label prominently displays the NDC 71085-099-24 and emphasizes dispensing with a medication guide.*

* 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.