Pregabalin
Product Images NDC 71610-361

Product Visual Gallery

This gallery contains 25 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-361). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, Llc, 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

Bottle Label 50 mg (71610 0350 30)

Pregabalin 50 mg capsules label showing a bottle container with 30 capsules. The label includes storage instructions to keep between 20-25 degrees Celsius and to store in a tightly closed container as defined by USP. The label notes it is Rx only with warnings about habit forming. Labeler information is Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN.*

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Bottle Label 300 mg (71610 0351 30)

Pregabalin 300 mg capsules packaging label showing a supply of 30 capsules. The label includes storage instructions, manufacturer information (Greenstone LLC, Peapack, NJ), and is identified as prescription only. The label features barcodes and lot and expiration date details.*

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Bottle Label 150 mg (71610 0352 53)

Pregabalin 150 mg capsules label from Aphena Pharma Solutions - Tennessee, LLC. The label indicates a package size of 60 capsules with storage instructions between 20-25 degrees Celsius. It includes manufacturer and lot information, barcodes, and typical prescription dispensing notes such as "RX Only" and warnings about prescription use.*

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Bottle Label 75 mg (71610 0356 53)

Pregabalin 75 mg capsules label for a 60-count bottle. The label includes storage instructions to keep between 20-25 degrees Celsius, states the medication is dispensed in a controlled room temperature environment, and warns it may be habit-forming. Labeler information shows Aphena Pharma Solutions - Tennessee, LLC, located in Cookeville, TN, with manufacturing details for Greenstone LLC and Peapack, NJ.*

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Bottle Label 100 mg (71610 0357 53)

Label for Pregabalin 100 mg capsules by Aphena Pharma Solutions - Tennessee, LLC, containing 60 capsules. The label includes storage instructions, lot number, expiration date, and warnings. It also mentions prescription (Rx) only and advises keeping the drug out of reach of children.*

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Bottle Label 225 mg (71610 0358 53)

Label for Pregabalin 225mg capsules, 60 count, manufactured by Greenstone LLC and packaged by Aphena Pharma Solutions - Tennessee, LLC, located in Cookeville, TN. The label includes storage instructions to keep between 20-25 degrees Celsius and out of reach of children, with a warning that the drug may be habit-forming.*

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Bottle Label 200 mg (71610 0361 53)

Pregabalin 200 mg capsules label showing the NDC 71610-0361-53 and a quantity of 60 capsules. The label includes storage instructions (20-25°C), dispensing instructions, and warnings. The manufacturer is Aphena Pharma Solutions - Tennessee, LLC, with the label also referencing Greenstone LLC and locations in Peapack, NJ, and Cookeville, TN.*

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Bottle Label 25 mg (71610 0365 53)

Pregabalin 25 mg capsules label showing a bottle containing 60 capsules. The label includes storage instructions, manufacturer information for Greenstone LLC in Peapack, NJ, and repacker details for Aphena Pharma in Cookeville, TN. The label also notes 'RX Only' and includes barcode and lot details.*

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Aphena Pharma Solutions (TN)

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Figure (Pregabalin 01)

A formula for calculating creatinine clearance (CLCr) based on age, weight, serum creatinine, and gender adjustment for females. This text panel provides a mathematical expression relevant to renal function assessment.*

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Chemical Structure (Pregabalin 02)

Chemical structure diagram of pregabalin, depicting its molecular arrangement with labeled functional groups including an amino group (NH2) and a carboxylic acid group (CO2H).*

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Figure 1 (Pregabalin 03)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. It compares Pregabalin at doses of 200 mg, 100 mg, and 25 mg taken three times a day, along with a placebo group, illustrating varying levels of patient improvement.*

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Figure 2 (Pregabalin 04)

A line graph comparing percent of patients improved versus percent improvement in pain from baseline. It shows two curves for Pregabalin 100 mg three times a day and placebo, illustrating higher patient improvement rates for Pregabalin across pain improvement percentages.*

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Figure 3 (Pregabalin 05)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. The graph compares four groups: Pregabalin 300 mg twice daily, Pregabalin 150 mg twice daily, Pregabalin 75 mg twice daily, and placebo. Percent improvement ranges from 0 to 100, with corresponding patient improvement percentages plotted for each treatment group.*

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Figure 4 (Pregabalin 06)

A line chart depicting the percent of patients improved plotted against the percent improvement in pain from baseline for three groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo. The chart shows a decline in the percent of patients improved as pain improvement increases across the groups.*

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Figure 5 (Pregabalin 07)

A line graph depicting percent improvement in pain from baseline on the x-axis versus percent of patients improved on the y-axis. It compares three groups: Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo, showing trends of patient improvement percentages at varying pain improvement levels.*

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Figure 6 (Pregabalin 08)

A bar chart displaying responder rate percentages from two studies labeled E1 and E3. Study E1 includes placebo and four dosages of a treatment measured in mg/day at various frequencies, with responder rates increasing from placebo to the highest dose. Study E3 compares placebo with two treatment dosages, also showing higher responder rates for the treatment groups compared to placebo. Percentages are shown on the y-axis and dosage categories on the x-axis. Sample sizes are indicated below each category.*

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Figure 7 (Pregabalin 09)

A line graph depicting seizure reduction median percentage change from baseline against dose (mg/day) across four studies labeled E1 BID, E2 TID, E3 BID, and E3 TID. The graph includes dose points up to 600 mg/day and shows significant p-values for differences compared to placebo, highlighting dose-dependent effects on seizure reduction.*

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Figure 8 (Pregabalin 10)

A bar chart showing the responder rate percentages for Pregabalin at doses of 2.5 mg/kg/day and 10 mg/kg/day compared to placebo. The x-axis lists Placebo, 2.5 mg/kg/day, and 10 mg/kg/day groups with corresponding subject counts (N=93, 103, and 96). The y-axis represents responder rate percentages ranging from 0 to 60%.*

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Figure 9 (Pregabalin 11)

A Kaplan-Meier curve graph showing the percentage of patients improved versus percent improvement in pain from baseline for Pregabalin at daily doses of 600 mg, 450 mg, 300 mg, and placebo. The graph uses different line styles to differentiate between doses and placebo, with percent improvement on the horizontal axis and percent of patients improved on the vertical axis.*

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Figure 10 (Pregabalin 12)

A Kaplan-Meier curve showing the estimated percentage of subjects without LTR over 180 days, comparing Pregabalin and Placebo groups. The x-axis represents days, and the y-axis shows the estimated percentage without LTR, illustrating a higher survival estimate for Pregabalin throughout the study period.*

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Figure 11 (Pregabalin 13)

A line graph showing the percentage of subjects improved from baseline to week 12 measured by BOCF. Two lines represent Pregabalin and Placebo groups, with the Pregabalin group showing higher improvement percentages across the range compared to Placebo. The x-axis indicates Percent Improved, and the y-axis shows Percent of Subjects Improved, with vertical markers at specific improvement percentages (30, 50, 70, 90).*

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Figure 12 (Pregabalin 14)

A line graph comparing the percent of subjects improved over a range of percentage improvement from baseline to week 16 according to BOCF. The graph has two lines: one solid line representing Pregabalin and one dashed line representing Placebo. The vertical axis shows the percent of subjects improved, and the horizontal axis shows the percent improvement from baseline to week 16.*

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Logo (Pregabalin 15)

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Logo (Pregabalin 15a)

* 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.