Pregabalin Capsule
Product Images NDC 25000-182

Product Visual Gallery

This gallery contains 30 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 25000-182). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Marksans Pharma Limited, 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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Prega-sec27 (Prega Sec27)

A mathematical formula illustrating the calculation of creatinine clearance (CLCr) based on patient age, weight, serum creatinine, and an adjustment factor for female patients. The formula uses age in years, weight in kilograms, and serum creatinine in mg/dL.*

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Prega-tab-4 (Prega Tab 4)

A data table presenting the incidence of various adverse events by body system and preferred term among patients taking Pregabalin capsules at doses of 75 mg/day, 150 mg/day, 300 mg/day, 600 mg/day, total Pregabalin group, and placebo group. It details percentages for events such as asthenia, accidental injury, peripheral edema, dizziness, somnolence, neuropathy, and visual disturbances, among others.*

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Prega-tab-5 (Prega Tab 5)

A data table showing the incidence rates (percentages) of various side effects grouped by body systems in patients treated with Pregabalin capsules at different daily dosages (75 mg, 150 mg, 300 mg, 600 mg, and all doses combined) compared to placebo. The table categorizes adverse events such as infections, digestive symptoms, metabolic disorders, nervous system effects, respiratory issues, special senses, and urogenital system effects.*

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Prega-tab-6 (Prega Tab 6)

A data table presenting the frequency percentages of various preferred body system terms and associated adverse events reported for Pregabalin treatment groups at doses of 150 mg/day, 300 mg/day, and 600 mg/day, compared to all Pregabalin groups combined and a placebo group. Categories include digestive system, metabolic and nutritional disorders, nervous system, and special senses, showing trends in incidence rates across doses and vs placebo.*

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Prega-tab-9 (Prega Tab 9)

A data table presenting the frequency of various adverse events by system organ class and preferred term across multiple dose groups of Pregabalin (150 mg/d, 300 mg/d, 450 mg/d, 600 mg/d and above) compared to placebo. The table details percentages of events such as dizziness, somnolence, fatigue, weight increase, and others, categorized by system organ classes including gastrointestinal, nervous system, psychiatric, and respiratory disorders.*

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Prega-tab-10 (Prega Tab 10)

A data table comparing adverse events reported in patients treated with Pregabalin (PGB) versus a placebo. The table is organized by system organ class and preferred term, listing various side effects such as dizziness, somnolence, dry mouth, fatigue, and more, with corresponding percentages for each group (PGB N=182, Placebo N=174).*

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Prega-11-desc (Prega 11 Desc)

Chemical structure of Pregabalin, depicting its molecular framework including a carboxylic acid group (CO2H) and an amine group (NH2) attached to a branched carbon skeleton.*

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Prega-figure-1 (Prega Figure 1)

A line graph showing percent improvement in pain from baseline on the X-axis and percent of patients improved on the Y-axis. The chart compares four groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, Pregabalin 25 mg three times a day, and placebo, illustrating patient improvement trends across these dosages.*

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Prega-figure-2 (Prega Figure 2)

A line graph comparing percent improvement in pain from baseline against the percent of patients improved. It includes two groups: one receiving Pregabalin 100 mg three times a day and a placebo group, showing greater improvement in the Pregabalin group across the range of pain improvement percentages.*

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Prega-figure-3 (Prega Figure 3)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. The graph compares Pregabalin dosages of 75 mg, 150 mg, and 300 mg taken twice a day to a placebo control, illustrating trends in patient improvement across different pain reduction percentages.*

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Prega-figure-4 (Prega Figure 4)

A line graph comparing percent improvement in pain from baseline with percent of patients improved for Pregabalin 100 mg three times a day, Pregabalin 200 mg three times a day, and placebo. The graph shows differences in patient improvement across these treatments.*

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Prega-figure-5 (Prega Figure 5)

A line graph comparing percent improvement in pain from baseline among patients treated with Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo. The y-axis shows percent of patients improved, and the x-axis represents percent improvement in pain from baseline, illustrating higher improvement rates with Pregabalin doses compared to placebo.*

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Prega-tab-11 (Prega Tab 11)

A data table presenting study results on daily doses of Pregabalin with dosing regimens (BID, TID, BID/TID), baseline seizure frequency per month, median percentage change from baseline, and p-values versus placebo across three study groups labeled E1, E2, and E3. It compares placebo and various Pregabalin doses ranging from 50 mg/day to 600 mg/day.*

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Prega-figure-6 (Prega Figu 6)

A bar graph comparing responder rates (%) across different dosage groups of Pregabalin in two studies (E1 and E3). The x-axis shows treatment groups including placebo and varying daily dosages, while the y-axis indicates responder rates from 0% to 60%. Results highlight increasing responder rates with higher doses of Pregabalin compared to placebo.*

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Prega-figure-7 (Prega Figu 7)

A line graph depicting the dose-related seizure reduction in median percent change from baseline across four studies labeled E1BD, E2T1D, E3B1D, and E3T1D. The x-axis shows dose in mg/day ranging from 0 to 600, while the y-axis shows median percent reduction in seizures from baseline. Data points have error bars, with p-values indicating statistical significance for each study at corresponding doses.*

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Prega-table-12 (Prega Table 12)

A data table presenting the effects of different daily doses of Pregabalin on seizure frequency over 28 days. The table includes groups receiving placebo, 2.5 mg/kg/day, and 10 mg/kg/day doses, showing the median baseline seizure frequency, median percentage change from baseline, percentage difference relative to placebo, and p-values comparing results to placebo.*

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Prega-fig-8 (Prega Fig 8)

A bar chart showing responder rates (%) for three groups: Placebo, 2.5 mg/kg/day, and 10 mg/kg/day. The placebo group has a responder rate of 22.6%, the 2.5 mg/kg/day group has 29.1%, and the 10 mg/kg/day group has 40.6%. The number of subjects (N) for placebo is 93 and for 10 mg/kg/day is 96, with the number for 2.5 mg/kg/day not clearly visible.*

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Prega-figure-9 (Prega Figure 9)

A line graph depicting percent improvement in pain from baseline on the x-axis against percent of patients improved on the y-axis, comparing Pregabalin doses of 300 mg, 400 mg, and 600 mg daily, with a placebo group. The graph shows decreasing percentages of patients improved as pain improvement percentage increases, with distinct lines for each dosage and placebo.*

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Prega-table-14 (Prega Table 14)

A data table titled 'Patient Global Impression of Change' presenting treatment groups with dosages in mg/day and corresponding percentages of any improvement along with 95% confidence intervals. Treatment groups include Placebo, PGB 300, PGB 450, and PGB 600 with improvement percentages ranging from 47.6% to 77.8%.*

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Prega-figure-10 (Prega Figure 10)

A Kaplan-Meier survival curve showing estimated percentage of subjects without LTR (loss to follow-up or treatment response) over 180 days comparing Pregabalin and placebo groups. The y-axis represents the estimated percentage of subjects without LTR, and the x-axis represents time in days. The Pregabalin group shows a higher percentage of subjects without LTR over time compared to placebo.*

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Prega-figure-11 (Prega Figure 11)

A line graph comparing the percent of subjects improved from baseline to week 12 between Pregabalin and placebo groups. The x-axis shows percent improvement from 0 to 100, and the y-axis shows the percent of subjects improved, demonstrating higher improvement rates with Pregabalin versus placebo over the range.*

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Prega-figure-12 (Prega Figure 12)

A line graph comparing the percentage of subjects improved from baseline to Week 16 BOCF between Pregabalin and Placebo groups. The x-axis represents percent improvement from 0 to 100, and the y-axis represents the percent of subjects improved from 0 to 100. Two lines show higher improvement percentages for Pregabalin compared to Placebo across the range.*

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Prega-25mg-90s (Prega 25mg 90s Label)

Pregabalin Capsules 25 mg oral capsule label from Marksans Pharma Limited. The label indicates a package containing 90 capsules with instructions including storage at 25°C and warnings about the inner safety foil seal. Manufacturer and distributor details are visible, along with the National Drug Code (NDC) 25000-179-07.*

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Prega-50mg-90s (Prega 50mg 90s Label)

Label for Pregabalin Capsules 50 mg by Marksans Pharma Limited. The label indicates the dosage strength as 50 mg per capsule and states the package contains 90 capsules. It includes storage instructions, manufacturer information, a barcode, and a note to dispense the accompanying medication guide to each patient. The label also shows the NDC number 25000-180-07.*

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Prega-75mg-90s (Prega 75mg 90s Label)

Label for Pregabalin Capsules 75 mg by Marksans Pharma Limited. The label indicates a 90-capsule package, with a prescription-only designation. It includes storage instructions, a barcode, and manufacturing details for Marksans Pharma Ltd., India, and Time-Cap Labs, Inc., USA. The label also cautions against use if the inner safety seal is broken or missing.*

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Prega-100mg-90s (Prega 100mg 90s Label)

Label for Pregabalin Capsules 100 mg by Marksans Pharma Limited, packaged in a container of 90 capsules. The label includes storage instructions, dosage warnings, and manufacturing details listing Time-Cap Labs, Inc. and Marksans Pharma Ltd. The barcode and NDC 25000-182-07 are shown, along with a note to dispense the medication guide to patients.*

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Prega-150mg-90s (Prega 150mg 90s Label)

Pregabalin Capsules 150 mg packaging label from Marksans Pharma Limited. The label indicates each capsule contains 150 mg of pregabalin and the package contains 90 capsules. It includes storage instructions, a barcode, and manufacturing details for Marksans Pharma Ltd. and Time-Cap Labs, Inc. The label also advises dispensing the accompanying medication guide to each patient.*

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Prega-200mg-90s (Prega 200mg 90s Label)

Pregabalin Capsules 200 mg oral capsules packaging label. The label indicates the product contains 90 capsules and is for prescription use only (Rx only). Manufactured by Marksans Pharma Ltd. and labeled for Time-Cap Labs, Inc. It includes storage instructions and a barcode.*

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Prega-225mg-90s (Prega 225mg 90s Label)

Label for Pregabalin Capsules 225 mg by Marksans Pharma Ltd. The label indicates 90 capsules per container, Rx only. Storage instructions advise 25°C with permitted excursions. Manufacturer details and barcode are visible. The label includes a warning about the safety foil seal.*

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Prega-300mg-90s (Prega 300mg 90s Label)

Pregabalin 300 mg capsules label showing product name, strength, and dosage form. The label indicates that each capsule contains 300 mg pregabalin, with a package size of 90 capsules. It is labeled for prescription use (Rx only). Manufactured by Marksans Pharma Ltd. for Time-Cap Labs, Inc., with storage instructions and safety warnings also visible.*

* 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.