Pregabalin Capsule
Product Images NDC 47335-686

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 47335-686). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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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Formula (Formula)

A mathematical formula image showing the calculation for creatinine clearance (CLcr). The formula accounts for age in years, weight in kilograms, serum creatinine in mg/dL, and includes a multiplier of 0.85 for female patients.*

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Chemical-structure (Chemical Structure)

Chemical structure of pregabalin, showing its molecular framework with an amino group (NH2) and a carboxylic acid group (CO2H) attached to a branched carbon chain.*

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Spl-pregabalin-figure1 (Spl Pregabalin Figure1)

A line graph showing patients achieving various levels of improvement in pain intensity in Study DPN 1. The x-axis represents percent improvement in pain from baseline, ranging from 0 to 100%, and the y-axis shows the percent of patients improved, from 0 to 100%. Four lines represent treatment groups: Pregabalin 200 mg three times daily, 100 mg three times daily, 25 mg three times daily, and placebo. Higher doses of pregabalin show greater patient improvement compared to placebo.*

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Spl-pregabalin-figure2 (Spl Pregabalin Figure2)

A line graph titled 'Patients Achieving Various Levels of Improvement in Pain Intensity– Study DPN 2' showing the percent of patients improved on the vertical axis versus percent improvement in pain from baseline on the horizontal axis. Two lines compare Pregabalin 100 mg three times a day and placebo groups across different pain improvement thresholds.*

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Spl-pregabalin-figure3 (Spl Pregabalin Figure3)

A line graph titled 'Patients Achieving Various Levels of Improvement in Pain Intensity – Study PHN 1,' showing percent of patients improved by percent improvement in pain from baseline. It compares Pregabalin dosages (300 mg, 150 mg, 75 mg two times a day) and placebo, with percent improved on the vertical axis and percent improvement in pain from baseline on the horizontal axis.*

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Spl-pregabalin-figure4 (Spl Pregabalin Figure4)

A line graph titled 'Patients Achieving Various Levels of Improvement in Pain Intensity – Study PHN 2', showing percent of patients improved on the y-axis versus percent improvement in pain from baseline on the x-axis. It compares three groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo, with lines depicting patient response rates across different improvement levels.*

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Spl-pregabalin-figure5 (Spl Pregabalin Figure5)

A line graph titled 'Patients Achieving Various Levels of Improvement in Pain Intensity – Study PHN 3' showing the percent of patients improved on the y-axis and percent improvement in pain from baseline on the x-axis. The graph 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). Both Pregabalin groups show higher percentages of patient improvement across pain reduction levels compared to placebo.*

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Spl-pregabalin-figure6 (Spl Pregabalin Figure6)

A bar chart titled 'Responder rate by Adjunctive epilepsy study' comparing responder rates (%) across different Pregabalin dosages and placebo groups in two studies (Study E1 and Study E3). The x-axis categorizes groups by dosage and dosing frequency, while the y-axis shows responder rates from 0% to 60%. Bars indicate responder percentages for placebo, 50 mg/day BID, 150 mg/day BID, 300 mg/day BID, and 600 mg/day BID in Study E1, and placebo, 600 mg/day BID, and 600 mg/day TID in Study E3. Some bars are marked as statistically significant versus placebo.*

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Spl-pregabalin-figure7 (Spl Pregabalin Figure7)

A line graph titled 'Seizure Reduction by Dose (All Partial Onset Seizures) for Studies E1, E2, and E3' showing median percentage change from baseline in seizure reduction. The x-axis represents dose in mg/day (0 to 600), and the y-axis shows seizure reduction percentages (0 to 60). Four studies are plotted with distinct markers: Study E1 BID (circles), Study E2 TID (squares), Study E3 BID (triangles), and Study E3 TID (open triangles). Significant p-values are displayed at various dose points, demonstrating dose-dependent seizure reduction.*

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Spl-pregabalin-figure 8.jpg.jpg (Spl Pregabalin Figure 8)

A bar chart illustrating responder rates (%) for three groups: Placebo (22.6%), 2.5 mg/kg/day (29.1%), and 10 mg/kg/day (40.6%). The sample sizes are 93, 103, and 96 respectively. The vertical axis represents responder rate percentages, and the horizontal axis shows the treatment groups.*

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Spl-pregabalin-figure9 (Spl Pregabalin Figure9)

A line graph titled 'Patients Achieving Various Levels of Improvement in Pain Intensity – Fibromyalgia Study F1' showing the percent of patients improved on the vertical axis against percent improved in pain from baseline on the horizontal axis. Four lines compare Pregabalin daily doses of 600 mg, 450 mg, 300 mg, and placebo, illustrating patient improvement percentages across different pain reduction ranges.*

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Spl-pregabalin-figure10 (Spl Pregabalin Figure10)

A Kaplan-Meier analysis graph titled 'Time to Loss of Therapeutic Response, Fibromyalgia Study F2'. The graph compares the estimated percentage of subjects without loss of therapeutic response (LTR) over 180 days between Pregabalin and placebo groups. Pregabalin shows a higher percentage of subjects without LTR throughout the study period compared to placebo.*

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Spl-pregabalin-figure11 (Spl Pregabalin Figure11)

A line graph titled 'Patients Achieving Various Levels of Improvement in Pain Intensity - Study SCI 1' comparing the percentage of subjects improved over different levels of percent improvement from baseline to week 12. The x-axis shows percent improvement from 0 to 100, and the y-axis shows the percent of subjects improved from 0 to 100. Two lines represent Pregabalin (solid line) and Placebo (dashed line), with Pregabalin consistently showing higher percentages of subjects improved at each level compared to Placebo.*

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Spl-pregabalin-figure12 (Spl Pregabalin Figure12)

A line graph titled 'Patients Achieving Various Levels of Improvement in Pain Intensity – Study SCI 2' comparing the percentage of subjects improved with Pregabalin versus Placebo over different percent improvement ranges from baseline to week 16 BOCF. The graph shows Pregabalin consistently with a higher percentage of improvement compared to Placebo across the improvement spectrum.*

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Pregabalin-25mg (Spl Pregabalin Label 25mg)

Label for Pregabalin Capsules, 25 mg strength, from Sun Pharmaceutical Industries, Inc. The label includes tablet count (100 capsules), instructions for pharmacist to dispense with Medication Guide, and storage conditions. The label shows the National Drug Code (NDC) 47335-686-88 and manufacturer information from India.*

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Pregabalin-50mg (Spl Pregabalin Label 50mg)

Label for Pregabalin Capsules 50 mg by Sun Pharmaceutical Industries, Inc. The label includes storage instructions (20° to 25°C), dispensing information, and a barcode. It states the product contains 100 capsules and requires a prescription. Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ.*

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Pregabalin-75mg (Spl Pregabalin Label 75mg)

Packaging label for Pregabalin Capsules 75 mg, an oral prescription drug by Sun Pharmaceutical Industries, Inc. The label shows the dosage strength prominently in green and includes storage instructions, dispensing guidelines, and a barcode. The label specifies 100 capsules per package and highlights pharmacist dispensing requirements and medication guide availability.*

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Pregabalin-100mg (Spl Pregabalin Label 100mg)

Label for Pregabalin Capsules 100 mg by Sun Pharmaceutical Industries, Inc., containing 100 capsules per container. The label includes storage instructions to keep between 20° to 25°C (68° to 77°F), dosage advisory, and pharmacist dispensing guidance. It features the NDC 47335-689-88 and a barcode along with manufacturer and distributor details.*

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Pregabalin-150mg (Spl Pregabalin Label 150mg)

Label for Pregabalin Capsules 150 mg by Sun Pharmaceutical Industries, Inc. The label states each capsule contains 150 mg of pregabalin USP with a package size of 100 capsules. It includes storage instructions at controlled room temperature, a reminder for pharmacists to dispense with a medication guide, and manufacturing details indicating the product is made in India.*

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Pregabalin-200mg (Spl Pregabalin Label 200mg)

Label for Pregabalin Capsules 200 mg by Sun Pharmaceutical Industries, Inc. The label indicates prescription-only status with 100 capsules per container. Storage instructions recommend maintaining 20° to 25°C with allowable excursions. The manufacturer is based in India, and the label includes usage and dispensing guidelines along with a barcode.*

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Pregabalin-225mg (Spl Pregabalin Label 225mg)

Label for Pregabalin Capsules 225 mg by Sun Pharmaceutical Industries, Inc. The label specifies oral capsules, packaged as 100 count. Storage instructions indicate 20° to 25°C with permitted excursions. It also notes dispensing with medication guide and includes distributor and manufacturer addresses in New Jersey, USA, and India respectively.*

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Pregabalin-300mg (Spl Pregabalin Label 300mg)

Label for Pregabalin 300 mg capsules by Sun Pharmaceutical Industries, Inc. The label includes dosage strength, directions to dispense with Medication Guide, storage instructions, manufacturer details (Sun Pharmaceutical Industries Ltd., India), and packaging of 100 capsules. The label features a barcode and the Sun Pharma 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.