Pregabalin Capsules, Cv Capsule
Product Images NDC 69097-682

Product Visual Gallery

This gallery contains 30 technical images submitted to the FDA as part of the official labeling for Pregabalin Capsules, Cv (NDC 69097-682). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cipla Usa 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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Image (03a1965c 9956 486f 8599 7f5ecbf6c3b5 01)

A formula for estimating creatinine clearance (CLCr) adjusted by age, weight, and serum creatinine levels, with a multiplication factor of 0.85 for female patients. The formula is presented as part of drug-related information, likely for dosing calculations.*

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Pregabalin (Structure)

Chemical structure diagram of the active ingredient pregabalin. The structure includes an amino group (NH2), carboxyl group (CO2H), and a branched hydrocarbon side chain indicating its molecular composition.*

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Study Dpn-1 (Figure 1)

A line graph showing percent of patients improved versus percent improvement in pain from baseline for Pregabalin capsules at 25 mg, 100 mg, and 200 mg taken three times a day, compared to placebo. The graph illustrates that higher doses of Pregabalin correspond with a greater percentage of patients experiencing pain improvement.*

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Study Dpn -2 (Figure 2)

A line graph comparing the percent of patients improved versus percent improvement in pain from baseline, for Pregabalin 100 mg three times a day and placebo groups. The x-axis represents percent improvement in pain, and the y-axis represents percent of patients improved, showing higher patient improvement with Pregabalin relative to placebo.*

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Study Phn-1 (Figure 3)

A line graph depicting the percent of patients improved versus percent improvement in pain from baseline. It compares multiple treatment groups: Pregabalin 300 mg twice daily, Pregabalin 150 mg twice daily, Pregabalin 75 mg twice daily, and placebo, showing the efficacy trends across different levels of pain improvement.*

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Study Phn-2 (Figure 4)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. The graph compares three groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo, illustrating differences in patient improvement rates for varying pain relief percentages.*

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Study Phn -3 (Figure 5)

A line graph showing the percent of patients improved plotted against percent improvement in pain from baseline. The graph compares Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo groups, illustrating their respective pain improvement outcomes over a range of percentages.*

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Adjunctive Epilepsy Study (Figure 6)

A bar graph comparing responder rates (%) across different doses and dosing schedules of Pregabalin capsules in two studies, labeled Study E1 and Study E3. Study E1 shows responder rates at placebo and five dosing levels (50 mg to 600 mg per day) with twice daily (BID) administration. Study E3 presents responder rates at placebo and 600 mg per day given either twice daily (BID) or three times daily (TID). Sample sizes (N) for each group are indicated below the bars.*

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Studies E1,e2,e3 (Figure 7)

A line graph depicting seizure reduction as median percentage change from baseline versus dose (mg/day) for Pregabalin in three studies, labeled Study E1 BID, Study E2 BID, and Study E3 BID. The graph shows dose values up to 600 mg/day and includes significant p-values at various dose points.*

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Graphfigure8 (Graph8)

A bar chart depicting responder rates (%) for Pregabalin capsules, CV at different dosages compared to placebo. The x-axis shows placebo, 2.5 mg/kg/day, and 10 mg/kg/day groups, while the y-axis shows responder rates from 0% to 60%. The chart includes numeric sample sizes for each group below the x-axis categories.*

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Fibromyalgia Study F1 (Figure 9)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. It compares Pregabalin doses of 300 mg, 450 mg, and 600 mg daily against placebo, with Pregabalin doses showing higher improvement percentages over placebo.*

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Kaplan-meier-analysis (Graph 10)

A Kaplan-Meier plot comparing the estimated percentage of subjects without LTR over a 180-day period. The graph shows two lines labeled Pregabalin (solid) and Placebo (dashed), depicting the survival curves for each group across days on the X-axis and percentage of subjects without LTR on the Y-axis.*

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Study Sci 1 (Graph 11)

A line graph comparing the percent of subjects improved over time from baseline to week 12 on the Brief Observation of Functioning in Caregiving (BOCF) scale. The x-axis represents percent improved from baseline to week 12, ranging from 0 to 100%, while the y-axis shows the percent of subjects improved, also from 0 to 100%. Two lines are shown: one solid line for Pregabalin and a dotted line for Placebo, illustrating higher improvement percentages for Pregabalin subjects across the range.*

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Study Sci 2 (Graph 12)

A line graph showing the percent of subjects improved over time comparing Pregabalin and placebo groups. The x-axis represents percent improvement from baseline to week 16 in BOCF, and the y-axis shows the percent of subjects improved, with lines for Pregabalin and placebo indicating difference in treatment response.*

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25mg (Carton)

Pregabalin Capsules CV 25 mg package label for oral capsules by Cipla USA Inc. The label includes storage instructions, dosage notes, pharmacist dispensing guidance, package quantity of 100 capsules (10 x 10 unit-dose), and manufacturing details from Cipla Ltd., India. It confirms the prescription-only status and dosage strength clearly in magenta text.*

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25 mg 90s Label (25mg90s)

Label for Pregabalin Capsules, CV 25 mg by Cipla USA Inc. The label includes dosage strength (25 mg), handling instructions to dispense the Medication Guide, storage conditions, manufacturer information in India and the US, total count (90 capsules), NDC number 69097-677-05, and a barcode. There is a designated area for batch overprinting including serial number, expiry date, and lot number.*

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50 mg Carton (Label)

Packaging label for Pregabalin capsules, 50 mg strength, oral dosage form, manufactured by Cipla USA Inc. The label states prescription-only status and contains storage instructions, dosage and use directions note, and packaging size of 100 capsules (10 x 10 unit-dose). Barcode and manufacturing details are also visible on the label.*

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50 mg 90s Label (50mg90s)

Label for Pregabalin Capsules, CV 50 mg by Cipla USA Inc. The label indicates a prescription drug with 90 capsules. It includes storage instructions, dosage guidance referencing accompanying information, and manufacturer details (Cipla Ltd., India). There is a designated area for batch overprinting including serial number, expiry, and lot information. The NDC code and barcode are also present.*

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Carton (75mglabel)

Packaging label for Pregabalin capsules, CV 75 mg, produced by Cipla USA Inc. The oral capsule bottle contains 100 capsules (10 x 10 units). The label includes storage instructions to keep at 25°C (77°F) with permitted excursions and warnings about child safety. Label also notes prescribing information availability and specifies the contents as 75 mg Pregabalin USP per capsule.*

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75 mg 90s Label (75mg90s)

Label for Pregabalin Capsules CV 75 mg by Cipla USA Inc., containing 90 capsules. The label includes dosage instructions to dispense accompanying medication guide, storage conditions at 25°C with permitted excursions, and manufacturer details in Maharashtra, India. It features a barcode and designated area for batch overprinting with serial number, expiry, and lot information.*

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Label (100mg)

Packaging label for Pregabalin Capsules 100 mg, oral capsules, manufactured by Cipla USA Inc. The label includes storage instructions, dosage information, and a note that 100 capsules (10 x 10 unit-dose) are included. The label is marked for prescription use only and features the Cipla logo.*

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100 mg 90s Label (100mg90s)

Label for Pregabalin Capsules, CV, 100 mg, presented by Cipla USA Inc. The label includes storage instructions, dosage form as capsules, a barcode, and a note to dispense the accompanying Medication Guide. It specifies manufacturing by Cipla Ltd. in Maharashtra, India and Cipla USA Inc. in New Jersey. The label is for a package containing 90 capsules with batch overprinting details for serial number, expiry, and lot number.*

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Carton (150mglabel)

Label for Pregabalin Capsules 150 mg by Cipla USA Inc. The label shows the dosage strength, prescription status (Rx Only), and storage instructions. It states the package contains 100 capsules (10 x 10 unit doses) and includes manufacturer information with Cipla, Ltd., Kurkumbh, India, as the manufacturer and Cipla USA, Inc. as the labeler.*

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150 mg 90s Label (150mg90s)

Label for Pregabalin capsules, CV 150 mg by Cipla USA Inc. The label specifies this is a prescription oral capsule drug with 90 capsules per package. It includes storage instructions, dispensing guidance, and manufacturer information. The label features the Cipla logo, a barcode, and space for batch overprinting details such as serial number, expiration date, and lot number.*

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Carton (200mglabel)

Packaging label for Pregabalin capsules, CV, 200 mg, manufactured by Cipla USA Inc. The label indicates oral capsules, with a package size of 100 capsules (10 x 10 unit dose). It includes storage instructions, dosage caution, and a barcode, with the Cipla logo and prescription-only notation.*

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200 mg 90s Label (200mg90s)

Label for Pregabalin Capsules, 200 mg, an oral prescription capsule by Cipla USA Inc. The label includes dosing and storage instructions, NDC 69097-683-05, barcode, quantity of 90 capsules, and manufacturing details showing Cipla Ltd., India, and Cipla USA, New Jersey. It directs pharmacists to dispense the accompanying Medication Guide.*

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Label (225mglabel)

Packaging label for Pregabalin capsules, CV 225 mg by Cipla USA Inc. The label indicates 100 capsules per bottle, for oral use, with storage instructions and regulatory information. The label includes the Cipla logo, NDC code, barcode, and manufacturing details.*

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225 mg 90s Label (225mg90s)

Label for Pregabalin Capsules 225 mg by Cipla USA Inc. The label indicates prescription use only, storage instructions, and dispensing directions. It includes the NDC number 69097-684-05, a statement to dispense the medication guide, and details the manufacturer as Cipla Ltd., India. The label shows space for batch information and barcodes on the right side.*

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Carton Label (300mg)

Packaging label for Pregabalin Capsules 300 mg by Cipla USA Inc. The label indicates 100 capsules (10 x 10 unit dose) in the package with storage instructions at 20°C to 25°C. The label includes directions to refer to the Medication Guide and prescribing information and states the product is for oral use only. Manufacturer details and a barcode are also visible.*

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300 mg 90s Count Label (300mg90s)

Label for Pregabalin Capsules, CV, 300 mg, manufactured by Cipla USA Inc. The label shows the product name, strength, dosage form (capsules), and directions for storage and use. It indicates 90 capsules per container and includes instructions to dispense the accompanying Medication Guide. The label includes barcode, batch overprinting area for serial number, expiry, and lot number, and manufacturer details.*

* 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.