Pregabalin
Product Images NDC 75834-296

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 75834-296). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nivagen 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.

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Chemical Structure (Pregabalin 01)

Chemical structure of pregabalin showing its molecular framework including an amino group and a carboxylic acid group attached to a branched carbon backbone.*

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Figure 1 (Pregabalin 02)

A line graph showing percent of patients improved versus percent improvement in pain from baseline, comparing Pregabalin dosages of 200 mg, 100 mg, 25 mg three times a day, and placebo. The y-axis represents the percent of patients improved, and the x-axis shows percent improvement in pain from baseline.*

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Figure 2 (Pregabalin 03)

This is a Kaplan-Meier plot graph showing the percent of patients improved (y-axis) versus percent improvement in pain from baseline (x-axis). It compares two groups: patients treated with Pregabalin 100 mg three times a day and placebo, showing higher improvement rates in the Pregabalin group throughout the measured pain improvement range.*

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Figure 3 (Pregabalin 04)

A line graph depicting the percent of patients improved versus percent improvement in pain from baseline for Pregabalin at doses of 75 mg, 150 mg, and 300 mg taken two times a day compared to placebo. The graph shows four curves, with higher doses of Pregabalin corresponding to greater patient improvement percentages.*

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Figure 4 (Pregabalin 05)

A line graph showing the percent of patients improved plotted against percent improvement in pain from baseline for Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo. The graph compares the efficacy of two Pregabalin dosages with placebo over varying improvement thresholds.*

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Figure 5 (Pregabalin 06)

A line graph showing the percent of patients improved on the vertical axis and percent improvement in pain from baseline on the horizontal axis. It compares three groups: Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo, with the Pregabalin 100 mg group generally showing higher improvement percentages.*

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Figure 6 (Pregabalin 07)

Bar graph depicting responder rates (%) in two clinical studies labeled E1 and E3 for PREGABALIN at various doses compared to placebo. Study E1 shows increasing responder rates with doses from 50 mg/day to 600 mg/day, with the 600 mg/day dose reaching 51%. Study E3 compares placebo, 600 mg/day BID, and 600 mg/day TID doses, with TID dosing showing the highest responder rate of 49%. The graph includes sample sizes (N) for each group and notes statistically significant differences versus placebo.*

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Figure 7 (Pregabalin 08)

A line graph illustrating seizure reduction as median percentage change from baseline plotted against dose in mg/day, ranging from 0 to 600. The graph includes data points from four studies labeled E1BD, E2TID, E3BD, and E3TID, each represented by different symbols. Significant p-values (≤ 0.0001 or 0.0007) are noted near the data points, indicating statistical significance of seizure reduction at various doses.*

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Figure 8 (Pregabalin 09)

A bar chart depicting responder rates (%) for three groups: Placebo (22.6%, n=93), Pregabalin 2.5 mg/kg/day (29.1%, n=103), and Pregabalin 10 mg/kg/day (40.6%, n=96). The x-axis shows treatment groups and sample sizes; the y-axis shows responder rates in percentage.*

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Figure 9 (Pregabalin 10)

A line graph showing the percent of patients improved plotted against percent improvement in pain from baseline for Pregabalin at different daily doses (600 mg, 300 mg, 45 mg) compared to placebo. The graph includes four curves representing each treatment group, tracking patient improvement across varying pain reduction percentages.*

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Figure 10 (Pregabalin 11)

A Kaplan-Meier survival curve graph comparing the estimated percentage of subjects without LTR over time (days) between Pregabalin and placebo groups. The y-axis represents the estimated percentage of subjects without LTR, ranging from 0% to 100%, and the x-axis shows days from 0 to 180. The graph illustrates a higher percentage of subjects without LTR in the Pregabalin group compared to placebo over the study period.*

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Figure 11 (Pregabalin 12)

A line graph comparing the percent of subjects improved over a range of percent improvement from baseline to Week 12, as measured by BOCF. The graph shows two lines: a solid line representing Pregabalin and a dotted line representing placebo, plotting the percent of subjects improved on the vertical axis against percent improvement on the horizontal axis.*

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Figure 12 (Pregabalin 13)

A line chart comparing the percent improved from baseline to Week 16 BOCF between Pregabalin and Placebo groups. The x-axis shows the percent improvement ranging from 0 to 100, while the y-axis displays the percent of subjects improved. The solid line represents Pregabalin results, and the dashed line represents Placebo results.*

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Principal Display Panel (25 mg Capsule Bottle Label)

Label for Pregabalin Capsules 25 mg by Nivagen Pharmaceuticals, Inc. The label states 60 capsules per bottle. It includes dosage information, storage instructions, and manufacturer details, highlighting Eskayef Pharmaceuticals Limited in Bangladesh and Nivagen Pharmaceuticals, Inc. in Sacramento, CA. The label also notes the product is Rx only and advises dispensing the accompanying Medication Guide.*

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Principal Display Panel (50 mg Capsule Bottle Label)

Label for Pregabalin Capsules 50 mg by Nivagen Pharmaceuticals, Inc. It states the product contains 50 mg pregabalin per capsule, with 60 capsules per container. Instructions include dispensing accompanying Medication Guide, storage temperature range, and child-resistant packaging. The label includes manufacturer details for Eskayef Pharmaceuticals Limited in Bangladesh and contact information for Nivagen Pharmaceuticals in Sacramento, CA.*

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Principal Display Panel (75 mg Capsule Bottle Label)

Pregabalin Capsules 75 mg label from Nivagen Pharmaceuticals, Inc. The packaging includes dosage form and strength, quantity of 60 capsules, and instructions for pharmacists to dispense accompanying Medication Guide. It shows storage instructions, manufacturing details by Eskayef Pharmaceuticals Limited in Bangladesh, and distributor information in Sacramento, CA, USA. A barcode is present on the right side.*

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Principal Display Panel (100 mg Capsule Bottle Label)

Label for Pregabalin Capsules 100 mg, packaged in a bottle containing 60 capsules. The label includes storage instructions, manufacturer details (Eskayef Pharmaceuticals Limited, Bangladesh), and labeler information (Nivagen Pharmaceuticals, Inc., Sacramento, CA). It notes the capsule strength, and that the product is prescription only (Rx only).*

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Principal Display Panel (150 mg Capsule Bottle Label)

Label for Pregabalin Capsules 150 mg by Nivagen Pharmaceuticals, Inc. The label states each capsule contains 150 mg pregabalin USP, with a package size of 60 capsules. Storage instructions and manufacturing details from Eskayef Pharmaceuticals Limited in Bangladesh are also visible.*

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Principal Display Panel (200 mg Capsule Bottle Label)

Label for Pregabalin Capsules 200 mg by Nivagen Pharmaceuticals, Inc. The label states each capsule contains 200 mg pregabalin, USP. It indicates a package size of 60 capsules and includes storage instructions (20° to 25°C with permitted excursions). The label identifies Eskayef Pharmaceuticals Limited as the manufacturer.*

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Principal Display Panel (225 mg Capsule Bottle Label)

Label for Pregabalin Capsules 225 mg from Nivagen Pharmaceuticals, Inc. The label states each capsule contains 225 mg pregabalin USP. It includes storage instructions, prescribing information references, and notes the product is Rx only. The label identifies Eskayef Pharmaceuticals Limited in Bangladesh as the manufacturer and provides a toll-free number for Nivagen Pharmaceuticals in Sacramento, CA. The package contains 60 capsules.*

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Principal Display Panel (300 mg Capsule Bottle Label)

Label for Pregabalin Capsules 300 mg, containing 60 capsules. Manufactured by Eskayef Pharmaceuticals Limited in Bangladesh, labeled for Nivagen Pharmaceuticals, Inc., Sacramento, CA. Includes dosage storage instructions and references child-resistant packaging. The packaging highlights 'Rx only' and includes the Nivagen logo.*

* 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.