Pregabalin Capsule
Product Images NDC 43547-506

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 43547-506). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Solco Healthcare Us, 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

Chemical Structure (Image 01)

Chemical Structure (Image 01)
Chemical structure diagram of pregabalin, the active ingredient in PREGABALIN capsules. The diagram depicts the molecular arrangement including an amino group and a carboxyl group.*
FDA Label Image

Figure 1 (Image 02)

Figure 1 (Image 02)
A line graph displaying percent of patients improved versus percent improvement in pain from baseline for Pregabalin oral capsules at doses of 25 mg, 100 mg, and 200 mg three times a day compared to placebo. The graph shows four curves and indicates varying efficacy across doses with higher doses generally associated with greater patient improvement.*
FDA Label Image

Figure 2 (Image 03)

Figure 2 (Image 03)
A line graph comparing percent improvement in pain from baseline to percent of patients improved between pregabalin 100 mg taken three times a day (dashed line) and placebo (dotted line). The x-axis represents percent improvement in pain ranging from >0 to 100%, and the y-axis shows the percent of patients improved from 0 to 100%. Vertical lines mark 30% and 50% improvement thresholds.*
FDA Label Image

Figure 3 (Image 04)

Figure 3 (Image 04)
A line graph showing percent of patients improved versus percent improvement in pain from baseline for pregabalin at 75 mg, 150 mg, and 300 mg doses taken twice a day, compared to placebo. The graph illustrates that higher doses correspond to higher percentages of patients reporting pain improvement.*
FDA Label Image

Figure 4 (Image 05)

Figure 4 (Image 05)
A line graph showing 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. The vertical axis represents the percent of patients improved, and the horizontal axis shows percent improvement in pain from baseline, with data points extending from >0 to 100 percent.*
FDA Label Image

Figure 5 (Image 06)

Figure 5 (Image 06)
A line graph showing percent of patients improved on the y-axis and percent improvement in pain from baseline on the x-axis. It compares three groups: pregabalin 100 mg three times a day (dashed line), pregabalin 50 mg three times a day (solid line), and placebo (dotted line), illustrating patient response distribution at different improvement levels.*
FDA Label Image

Figure 6 (Image 07)

Figure 6 (Image 07)
A bar chart displaying responder rates (%) in two clinical studies labeled Study E1 and Study E3. Study E1 shows responder rates for placebo and pregabalin doses from 50 mg/day to 600 mg/day taken twice daily (BID). Study E3 compares placebo to 600 mg/day doses taken twice daily (BID) and three times daily (TID). The Y-axis measures responder rate percentage, and sample sizes (N) are noted below each group. Statistically significant differences versus placebo are marked.*
FDA Label Image

Figure 7 (Image 08)

Figure 7 (Image 08)
A line graph displaying seizure reduction as median percent change from baseline versus pregabalin dose in mg/day. It compares results from four studies with different dosing regimens (E1 BID, E2 TID, E3 BID, E3 TID). Significant p-values are indicated at various dose points, with seizure reduction increasing as dose increases up to 600 mg/day.*
FDA Label Image

Figure 9 (Image 09)

Figure 9 (Image 09)
A line chart comparing the percent of patients improved versus percent improvement in pain from baseline for pregabalin daily doses of 600 mg, 450 mg, 300 mg, and a placebo group. The chart shows four distinct trend lines illustrating patient responses at various pain improvement percentages.*
FDA Label Image

Figure 10 (Image 10)

Figure 10 (Image 10)
A Kaplan-Meier survival curve graph comparing the estimated percentage of subjects without LTR (loss to response) over days in a study involving pregabalin versus placebo. The x-axis represents days from 0 to 180, and the y-axis shows the estimated percentage of subjects without LTR from 0% to 100%. Two lines are shown: a solid line for pregabalin and a dashed line for placebo, illustrating higher survival without LTR for pregabalin over the study period.*
FDA Label Image

Figure 11 (Image 11)

Figure 11 (Image 11)
A line graph showing the percentage of subjects improved from baseline to Week 12 BOCF comparing Pregabalin and Placebo. The x-axis represents percent improvement, ranging from >0 to 100, and the y-axis shows the percent of subjects improved, ranging from 0 to 100. Pregabalin shows a higher percentage of subjects improved across the range compared to Placebo, which is represented by a dashed line.*
FDA Label Image

Figure 12 (Image 12)

Figure 12 (Image 12)
A line graph comparing the percent of subjects improved over time from baseline to week 16 using BOCF method. It shows two curves: one solid line for pregabalin and one dashed line for placebo, with the pregabalin line consistently above the placebo line. The x-axis represents percent improved from baseline to week 16, and the y-axis shows the percent of subjects improved.*
FDA Label Image

Cockcroft And Gault Equation (Image 13)

Cockcroft And Gault Equation (Image 13)
A mathematical formula depicting the calculation of creatinine clearance (CLcr), involving age, weight, serum creatinine levels, and a multiplier adjustment for female patients. This text panel is part of the prescribing or dosing information related to creatinine clearance calculation.*
FDA Label Image

25 mg (Image 14)

25 mg (Image 14)
Label for Pregabalin Capsules 25 mg by Solco Healthcare US, LLC. The label states each capsule contains 25 mg pregabalin and includes storage instructions and manufacturing details from Zhejiang Huahai Pharmaceutical Co., Ltd., China. The package contains 90 capsules and includes a reminder for pharmacists to dispense the Medication Guide separately.*
FDA Label Image

50 mg (Image 15)

50 mg (Image 15)
Label for Pregabalin Capsules 50 mg by Solco Healthcare US, LLC. The label includes dosage instructions, storage conditions, and manufacturer information (Zhejiang Huahai Pharmaceutical Co., Ltd., China). It indicates a package size of 90 capsules and features a barcode and a link to a medication guide.*
FDA Label Image

75mg (Image 16)

75mg (Image 16)
Pregabalin Capsules 75 mg label from Solco Healthcare US, LLC. The label includes dosage information, storage instructions, prescribing information reference, and manufacturer details (Zhejiang Huahai Pharmaceutical Co., Ltd., China). It indicates a package size of 90 capsules and states "Rx only." The label features a blue and yellow design with the product name prominently displayed.*
FDA Label Image

100 mg (Image 17)

100 mg (Image 17)
Label for Pregabalin Capsules 100 mg by Solco Healthcare US, LLC. The label includes dosage and use information, storage instructions, a website link for the medication guide, and identifies the manufacturer as Zhejiang Huahai Pharmaceutical Co., Ltd., China. The package contains 90 capsules and displays the NDC 43547-509-09.*
FDA Label Image

150 mg (Image 18)

150 mg (Image 18)
Label for Pregabalin Capsules 150 mg, human prescription drug in oral capsule form. The label shows the product name, strength, and quantity of 90 capsules. It is manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd. in China and distributed by Solco Healthcare US, LLC. Storage instructions and a website for the medication guide are also included.*
FDA Label Image

200 mg (Image 19)

200 mg (Image 19)
Label for Pregabalin Capsules, 200 mg strength, oral capsules by Solco Healthcare US, LLC. The package contains 90 capsules. The label includes storage instructions, manufacturer Zhejiang Huahai Pharmaceutical Co., Ltd, and distribution information. It also features a barcode and a medication guide note for pharmacists.*
FDA Label Image

225 mg (Image 20)

225 mg (Image 20)
Label for Pregabalin capsules containing 225 mg of pregabalin per capsule. The label indicates 90 capsules per container and instructs pharmacists to dispense the medication guide separately. The product is manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd. and distributed by Solco Healthcare US, LLC. Storage instructions and a barcode are also visible.*
FDA Label Image

300 mg (Image 21)

300 mg (Image 21)
Label for Pregabalin Capsules 300 mg by Solco Healthcare US, LLC. The label includes dosage instructions, storage conditions, manufacturer Zhejiang Huahai Pharmaceutical Co., Ltd in China, and distributor Solco Healthcare US, LLC. The package contains 90 capsules and features a blue and white design with the product name prominently displayed.*
FDA Label Image

Figure 8 (Image 22)

Figure 8 (Image 22)
A bar chart showing responder rates (%) for three groups: Placebo, 2.5 mg/kg/day, and 10 mg/kg/day, with respective sample sizes indicated below each category. The graph compares response percentages among these groups.*

* 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.