Pregabalin Capsule
Product Images NDC 65862-764

Product Visual Gallery

This gallery contains 30 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 65862-764). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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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Pregabalin Equation (Pregabalin Equ)

A formula displaying the Cockcroft-Gault Creatinine Clearance (CLCr) equation used to estimate kidney function, adjusting for patient age, weight, sex, and serum creatinine levels in mg/dL.*

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Figure 1: Patients Achieving Various Levels Of Improvement In Pain Intensity – Study Dpn 1 (Pregabalin Fig1)

A line graph titled 'Patients Achieving Various Levels of Improvement in Pain Intensity – Study DPN 1' showing percent of patients improved versus percent improvement in pain from baseline. It compares Pregabalin 200 mg, 100 mg, and 25 mg taken three times a day with placebo for pain improvement.*

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Figure 10 (Pregabalin Fig10)

Kaplan-Meier analysis chart showing Time to Loss of Therapeutic Response (LTR) in a Fibromyalgia Study F2, comparing Pregabalin and Placebo. The y-axis represents the estimated percentage of subjects without LTR, and the x-axis represents days up to 180. Pregabalin shows a higher percentage of subjects without LTR over time than placebo.*

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Figure 11 (Pregabalin Fig11)

A line graph comparing the percent of subjects improved from baseline to week 12 BOCF between Pregabalin and placebo groups. The x-axis represents percent improvement from 0 to 100, while the y-axis shows the percent of subjects improved. The Pregabalin line shows higher improvement rates compared to the placebo dotted line throughout the range.*

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Figure 12 (Pregabalin Fig12)

A line graph comparing the percent of subjects improved over time from baseline to week 16, measuring the efficacy of Pregabalin versus placebo using the BOCF method. The x-axis represents percent improvement from 0 to 100, and the y-axis represents percent of subjects improved from 0% to 100%. The graph shows two lines: a solid line for Pregabalin and a dashed line for placebo, illustrating higher improvement percentages for Pregabalin at most levels.*

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Package Label-principal Display Panel (25 mg (90 Capsules Bottle))

Pregabalin Capsules 25 mg label from Aurobindo Pharma Limited. The label states each capsule contains 25 mg pregabalin, includes storage instructions, distributor information for Aurobindo Pharma USA, and notes a package count of 90 capsules. The label features a barcode and references prescription use only.*

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Package Label-principal Display Panel (25 mg 100 (10 x 10) Unit-dose Capsules)

Packaging label for Pregabalin Capsules 25 mg in unit-dose format. The label indicates 100 capsules (10x10) with NDC 65862-758-78, distributed by Aurobindo Pharma USA, Inc. It notes storage instructions, prescription status (Rx only), and includes a pharmacist advisory to dispense the Medication Guide. Capsules are labeled as made in India by Aurobindo Pharma Limited.*

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Package Label-principal Display Panel (50 mg (90 Capsules Bottle))

Packaging label for Pregabalin Capsules 50 mg by Aurobindo Pharma Limited. The label shows a bottle containing 90 capsules, with the NDC number 65862-759-90. It includes storage instructions, distributor information for Aurobindo Pharma USA, Inc. in East Windsor, NJ, and the mention that the product is made in India. The label also advises dispensing in tight containers and includes a pharmacist's note to provide the Medication Guide separately.*

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Package Label-principal Display Panel (50 mg 100 (10 x 10) Unit-dose Capsules)

Packaging label for Pregabalin Capsules 50 mg in unit-dose form, containing 100 capsules (10 x 10). The label indicates the product is prescription only, manufactured by Aurobindo Pharma Limited, and distributed by Aurobindo Pharma USA, Inc. The label includes storage instructions and barcodes, with branding elements and NDC number 65862-759-78.*

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Package Label-principal Display Panel (75 mg (90 Capsules Bottle))

Label for Pregabalin Capsules 75 mg, a drug for further processing supplied by Aurobindo Pharma Limited. The label states each capsule contains 75 mg Pregabalin USP and the package contains 90 capsules. Storage instructions specify 20°C to 25°C, and dispensing guidelines instruct pharmacists to provide accompanying medication guides. Distributed by Aurobindo Pharma USA, Inc., made in India.*

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Package Label-principal Display Panel (75 mg 100 (10 x 10) Unit-dose Capsules)

Box label for Pregabalin Capsules 75 mg, a drug for further processing in capsule form. The label indicates a package size of 100 (10 x 10) unit-dose capsules. The labeler is Aurobindo Pharma Limited, with distribution by Aurobindo Pharma USA, Inc. The label includes dosing reminder, storage instructions, a barcode, and a caution that the unit-dose package is not child resistant.*

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Package Label-principal Display Panel (100 mg (90 Capsules Bottle))

Label for Pregabalin Capsules 100 mg by Aurobindo Pharma Limited, intended for further processing. The label states each capsule contains 100 mg Pregabalin USP and provides storage instructions at 20° to 25°C. It includes distributor information for Aurobindo Pharma USA, Inc., a note to dispense medication guides, and package size of 90 capsules. Barcode and coding area are also visible.*

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Figure 2: Patients Achieving Various Levels Of Improvement In Pain Intensity – Study (Pregabalin Fig2)

A line graph titled 'Patients Achieving Various Levels of Improvement in Pain Intensity - Study DPN 2' comparing percent of patients improved against percent improvement in pain from baseline. It shows two lines representing Pregabalin 100 mg three times a day and placebo, illustrating higher patient improvement percentages with Pregabalin across increasing pain improvement levels.*

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Package Label-principal Display Panel (100 mg 100 (10 x 10) Unit-dose Capsules)

Packaging label for Pregabalin Capsules 100 mg produced by Aurobindo Pharma Limited. The label indicates 100 unit-dose capsules (10 x 10) with a prescription-only (Rx only) warning. It includes storage instructions, dispensing information, a barcode, and distributor details for Aurobindo Pharma USA, Inc.*

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Package Label-principal Display Panel (150 mg (90 Capsules Bottle))

Packaging label for Pregabalin Capsules 150 mg by Aurobindo Pharma Limited. The label indicates the product is prescription only, contains 90 capsules, and includes storage instructions at 20° to 25°C. Distributed by Aurobindo Pharma USA, Inc. with address in East Windsor, NJ. Made in India. NDC 65862-762-90 is shown along with a barcode and medication guide instructions for pharmacists.*

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Package Label-principal Display Panel (150 mg 100 (10 x 10) Unit-dose Capsules)

Packaging label for Pregabalin Capsules 150 mg in unit-dose form. The label indicates 100 capsules (10 x 10 unit-dose capsules) and shows that it is Rx only. The labeler is Aurobindo Pharma Limited, with distribution by Aurobindo Pharma USA, Inc., made in India. The label includes storage instructions, a barcode, and a drug warning about child resistance for outpatient use.*

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Package Label-principal Display Panel (200 mg (90 Capsules Bottle))

Label for Pregabalin Capsules 200 mg, a prescription drug for further processing. The label shows the active ingredient strength, NDC 65862-763-90, quantity of 90 capsules, and storage instructions. Distributed by Aurobindo Pharma USA, Inc., made in India, with the Aurobindo logo and pharmacy dispensing reminder.*

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Package Label-principal Display Panel (200 mg 100 (10 x 10) Unit-dose Capsules)

Packaging label for Pregabalin Capsules 200 mg in unit-dose form. The label shows the product name, strength, and dosage form prominently, with instructions for pharmacists to dispense a Medication Guide. The package contains 100 (10 x 10) unit-dose capsules and is distributed by Aurobindo Pharma USA, Inc. Storage instructions and dosage guidance are also included on the label.*

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Package Label-principal Display Panel (225 mg (90 Capsules Bottle))

Label for Pregabalin Capsules 225 mg by Aurobindo Pharma Limited. The label states the product is for prescription use only (Rx only) and contains 90 capsules. It includes storage instructions (20° to 25°C) and mentions dispensing in tight containers. Distributed by Aurobindo Pharma USA, Inc., made in India, with a barcode and NDC 65862-764-90.*

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Package Label-principal Display Panel (225 mg 100 (10 x 10) Unit-dose Capsules)

This is a packaging label for Pregabalin Capsules, 225 mg, manufactured by Aurobindo Pharma Limited. The label indicates the product contains 100 (10 x 10) unit-dose capsules. It includes storage instructions, dosage caution, and a barcode. The label also notes that the package is not child-resistant and advises dispensing the medication guide to patients.*

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Package Label-principal Display Panel (300 mg (90 Capsules Bottle))

Label for Pregabalin Capsules 300 mg by Aurobindo Pharma Limited. The label indicates it is for prescription use only with a package count of 90 capsules. Distributed by Aurobindo Pharma USA, Inc., the label provides storage instructions and notes the product is made in India. The National Drug Code (NDC) 65862-765-90 is visible along with a barcode.*

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Package Label-principal Display Panel (300 mg 100 (10 x 10) Unit-dose Capsules)

Packaging label for Pregabalin Capsules 300 mg by Aurobindo Pharma Limited. The label indicates the product is Rx only and dispensed in unit-dose capsules, with a package size of 100 (10 x 10) capsules. The label includes storage instructions, prescribing information references, barcodes, and distributor details for Aurobindo Pharma USA, Inc.*

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Figure 3: Patients Achieving Various Levels Of Improvement In Pain Intensity – Study Phn 1 (Pregabalin Fig3)

A line graph titled "Patients Achieving Various Levels of Improvement in Pain Intensity – Study PHN 1," showing percent of patients improved versus percent improvement in pain from baseline. Four lines represent Pregabalin at doses 300 mg, 150 mg, 75 mg twice a day, and placebo. The graph illustrates varying levels of pain improvement across these groups.*

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Figure 4: Patients Achieving Various Levels Of Improvement In Pain Intensity – Study Phn 2 (Pregabalin Fig4)

A line graph titled 'Patients Achieving Various Levels of Improvement in Pain Intensity – Study PHN 2.' It depicts the percent of patients improved on the y-axis (0-100%) against percent improvement in pain from baseline on the x-axis (0-100%). Three lines represent treatment groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo. The graph shows higher percentages of patient improvement with Pregabalin compared to placebo across the range of pain improvement percentages.*

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Figure 5: Patients Achieving Various Levels Of Improvement In Pain Intensity – Study Phn 3 (Pregabalin Fig5)

A line graph titled 'Patients Achieving Various Levels of Improvement in Pain Intensity – Study PHN 3' showing percent of patients improved (0-100%) on the vertical axis and percent improvement in pain from baseline (0-100%) on the horizontal axis. It compares Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo across varying pain improvement percentages.*

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Figure6 (Pregabalin Fig6)

A bar chart showing responder rates (%) for pregabalin versus placebo across two studies (E1 and E3). Study E1 compares responder rates for placebo and various pregabalin doses (50 mg/day to 600 mg/day, all BID). Study E3 shows responder rates for placebo, 600 mg/day BID, and 600 mg/day TID dosing. Percentages above each bar indicate response rates, demonstrating increased response with higher pregabalin doses.*

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Figure7 (Pregabalin Fig7)

A line graph showing seizure reduction (median % change from baseline) on the vertical axis versus dose (mg/day) on the horizontal axis for pregabalin in studies E1, E2, and E3. Data points indicate significant seizure reduction at increasing doses for BID and TID regimens across the studies, with p-values indicating statistical significance.*

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Figure 8 (Pregabalin Fig8)

A vertical bar chart displaying responder rates (percentage) for three groups: Placebo (22.6%), 2.5 mg/kg/day dose (29.1%), and 10 mg/kg/day dose (40.6%). The sample sizes for each group are shown below the bars: Placebo (93), 2.5 mg/kg/day (103), and 10 mg/kg/day (96).*

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Figure 9 (Pregabalin Fig9)

A line graph titled 'Patients Achieving Various Levels of Improvement in Pain Intensity – Fibromyalgia Study F1' comparing the percent of patients improved against the percent improvement in pain from baseline. It includes four lines representing daily doses of Pregabalin at 600 mg, 450 mg, 300 mg, and Placebo, showing trends of patient improvement across various pain relief levels.*

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Chemical Structure (Pregabalin Str)

Chemical structure diagram of pregabalin showing its molecular arrangement with a carboxylic acid group, amino group, and carbon backbone.*

* 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.