Pregabalin Capsule
Product Images NDC 71610-320

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-320). 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.

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Bottle Label 25 mg (71610 0313 30)

Pregabalin 25 mg capsules packaging label showing a count of 30 capsules. The label includes storage instructions to keep at 20-25 degrees Celsius, dispensing instructions, and warnings about habit-forming potential. Manufactured by Invagen Pharmaceuticals Inc. for Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN.*

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Bottle Label 50 mg (71610 0314 30)

Pregabalin 50 mg capsules label from Aphena Pharma Solutions - Tennessee, LLC. The label includes storage instructions to keep between 20-25°C, a caution not to reuse the container, and to keep out of reach of children. Manufacturer is listed as Invagen Pharmaceuticals Inc. The bottle contains 30 capsules. The label displays barcodes, lot number, and a warning about possible fetal harm.*

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Bottle Label 75 mg (71610 0315 30)

Packaging label for Pregabalin 75 mg capsules, containing 30 capsules. The label includes storage instructions, dispensing requirements, manufacturer information (Invagen Pharmaceuticals Inc. and Aphena Pharma Solutions - Tennessee, LLC), and notes that the medication is prescription only (RX) with a warning about potential habit-forming effects.*

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Bottle Label 100 mg (71610 0316 30)

Pregabalin 100 mg capsules label from Aphena Pharma Solutions - Tennessee, LLC. The label includes storage instructions, manufacturer details (Invagen Pharmaceuticals Inc.), and supplies information on packaging and lot numbers. It specifies the product is for prescription use only and includes warnings about habit forming potential, with a package size of 30 capsules.*

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Bottle Label 150 mg (71610 0317 30)

Pregabalin 150 mg capsules label showing package of 30 capsules. The label includes storage instructions to keep between 20-25 degrees Celsius and keep out of reach of children. It advises to see the USP Controlled Room Temperature guidelines and use a tight, light-resistant container. Manufactured by Ivenix Pharmaceuticals Inc. in Hauppauge, NY and labeled by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. The label also notes the product is RX only and includes barcodes and batch information.*

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Bottle Label 200 mg (71610 0318 53)

Pregabalin 200 mg capsules label from Aphena Pharma Solutions - Tennessee, LLC. The label includes storage instructions, manufacturer Invagen Pharmaceuticals Inc., packaging done by Aphena Pharma Solutions in Cookeville, TN. It indicates 60 capsules per container and includes barcodes, lot number, and expiration details.*

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Bottle Label 225 mg (71610 0319 53)

Pregabalin 225 mg capsules label from Aphena Pharma Solutions - Tennessee, LLC. The label shows NDC 71610-0319-53, package of 60 capsules. Storage instructions include keeping at controlled room temperature and out of reach of children. Manufactured by Invagen Pharmaceuticals Inc., Hauppauge, NY, and packed by Aphena Pharma in Cookeville, TN. The label indicates prescription use only and includes a warning that the drug may be habit-forming.*

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Bottle Label 300 mg (71610 0320 30)

Pregabalin 300 mg capsules packaging label by Aphena Pharma Solutions - Tennessee, LLC. The label includes storage instructions, a warning that the drug may be habit forming, and indicates it is prescription only. The label also shows manufacturing details by Invagen Pharmaceuticals Inc., lot number, and expiration date information. The package contains 30 capsules.*

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Aphena Pharma Solutions (TN)

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Figure 1 (Pregabalincaps Fig01)

A line graph showing percent of patients improved versus percent improvement in pain from baseline for Pregabalin at doses of 25 mg, 100 mg, and 200 mg taken three times a day, compared to placebo. The x-axis represents percent pain improvement from baseline, and the y-axis represents percent of patients improved. Different line styles distinguish the doses and placebo.*

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Figure 2 (Pregabalincaps Fig02)

A Kaplan-Meier-like curve graph comparing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin 100 mg three times a day and placebo. The vertical axis represents the percent of patients improved, and the horizontal axis represents the percent improvement in pain from baseline, with two distinct lines for the treatment and placebo groups.*

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Figure 3 (Pregabalincaps Fig03)

A line graph showing the percentage of patients improved versus percent improvement in pain from baseline. It compares four groups: Pregabalin 300 mg twice a day, Pregabalin 150 mg twice a day, Pregabalin 75 mg twice a day, and placebo, illustrating the efficacy of different Pregabalin doses in pain improvement.*

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Figure 4 (Pregabalincaps Fig04)

A line graph depicting the percent of patients improved versus percent improvement in pain from baseline. It compares three groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo, showing differing levels of pain improvement over a range from 0 to 100 percent.*

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Figure 5 (Pregabalincaps Fig05)

A graph showing percent of patients improved versus percent improvement in pain from baseline, comparing Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo. The plot features three dose response curves indicating varying levels of pain improvement among patients for each treatment group.*

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Figure 6 (Pregabalincaps Fig06)

A bar chart comparing responder rates (%) across dosing groups of Pregabalin and placebo in Study E1 and Study E3. The x-axis shows different doses of Pregabalin and placebo groups, while the y-axis represents responder rates as percentages. The chart includes sample sizes for each group and indicates statistical significance versus placebo.*

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Figure 7 (Pregabalincaps Fig07)

A line graph depicting seizure reduction as median percentage change from baseline versus dose of Pregabalin in mg/day. The graph includes data points for four studies labeled E1 BD, E2 TID, E3 BD, and E3 TID, showing increasing seizure reduction with higher doses. Significant p-values are indicated for several data points. The x-axis shows dose from 0 to 600 mg/day, and the y-axis shows seizure reduction from 0 to 60%.*

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Figure 8 (Pregabalincaps Fig08)

A line graph comparing percent improvement in pain from baseline against the percent of patients improved. It displays four curves representing Pregabalin at 300 mg, 450 mg, and 800 mg daily doses, and a placebo. The graph shows that higher doses of Pregabalin correspond with greater pain improvement percentages among patients.*

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Figure 9 (Pregabalincaps Fig09)

This is a Kaplan-Meier survival curve graph comparing the estimated percentage of subjects without LTR (loss to response) over a period of 180 days for Pregabalin versus placebo. The y-axis shows the estimated percentage of subjects without LTR, and the x-axis shows the number of days. The graph includes two lines, one solid representing Pregabalin and one dashed representing placebo, illustrating differences in subject response rates over time.*

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Figure 11 (Pregabalincaps Fig10)

A line graph comparing the percent of subjects improved over a range of percent improvement from baseline to week 12 in a BOCF analysis. Two lines are shown: a solid line for Pregabalin and a dashed line for Placebo. The x-axis represents percent improved from baseline to week 12 BOCF, and the y-axis represents the percent of subjects improved, ranging from 0 to 100.*

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Figure 12 (Pregabalincaps Fig11)

A line graph comparing the percent of subjects improved versus the percent improvement from baseline to week 16 for Pregabalin and placebo groups. The x-axis represents percent improved from baseline to week 16 BOCF, ranging from >0 to 100. The y-axis represents percent of subjects improved, ranging from 0 to 100. The graph displays two lines: a solid line for Pregabalin and a dashed line for placebo.*

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Cockcroft And Gault Equation (Pregabalincaps Formula)

A mathematical formula used to calculate creatinine clearance (CLcr) based on age, weight, serum creatinine, and a correction factor for female patients. The formula specifies CLcr equals (140 minus age in years) times weight in kilograms, divided by 72 times serum creatinine in mg/dL, multiplied by 0.85 for females.*

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Chemical Structure (Pregabalincaps Str)

Chemical structure of Pregabalin, depicting its molecular arrangement with labeled functional groups including an amino group and a carboxyl group.*

* 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.