Pregabalin Capsule
Product Images NDC 69097-962

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 69097-962). 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.

FDA Label Image

Principal Display Panel (100 mg)

Pregabalin 100 mg capsules label displaying the dosage strength and quantity of 90 capsules. The label shows the NDC 69097-957-05 and states the product is Rx Only. Manufacturer information includes InvaGen Pharmaceuticals Inc., a Cipla Ltd. subsidiary, and Cipla USA, Inc. It includes storage instructions, a note to see the package insert for dosage, and child-resistant packaging information. Barcodes and a QR code are also visible.*

FDA Label Image

Principal Display Panel (150 mg)

Pregabalin Capsules 150 mg label by Cipla USA, Inc. The label states each capsule contains 150 mg pregabalin USP. It includes dispensing instructions for pharmacists and storage conditions at 20° to 25°C. The package contains 90 capsules. Manufacturer information lists InvaGen Pharmaceuticals, Inc., a Cipla subsidiary. A barcode and QR code are also visible.*

FDA Label Image

Principal Display Panel (200 mg)

Pregabalin 200 mg capsules label showing the product name, dosage strength, and quantity of 90 capsules. The label includes manufacturer information: InvaGen Pharmaceuticals, Inc., a subsidiary of Cipla Ltd., with address details. It notes that the medicine is prescription only, child-resistant packaging, storage instructions, and a QR code. Cipla USA, Inc. is listed as the labeler.*

FDA Label Image

Principal Display Panel (225 mg)

Pregabalin Capsules 225 mg label for a container of 90 capsules. The label includes dispensing instructions for pharmacists, storage conditions, and manufacturing information, including InvaGen Pharmaceuticals, Inc. and Cipla USA, Inc. The label displays the NDC 69097-961-05 and a barcode.*

FDA Label Image

Principal Display Panel (25 mg)

Pregabalin 25 mg capsules label by Cipla USA, Inc. The label indicates 90 capsules per package, child-resistant packaging, and instructions to dispense a Medication Guide to each patient. It includes storage instructions (20° to 25°C) and manufacturing details by InvaGen Pharmaceuticals and Cipla USA. The label also features a barcode and NDC 69097-954-05.*

FDA Label Image

Principal Display Panel (300 mg)

Label for Pregabalin Capsules 300 mg by Cipla USA, Inc. The label states the product is prescription only and contains 90 capsules. It includes instructions to dispense the Medication Guide separately and storage conditions. The label identifies the manufacturer as InvaGen Pharmaceuticals, Inc., a Cipla subsidiary.*

FDA Label Image

Principal Display Panel (50 mg)

Pregabalin 50 mg capsules label from Cipla USA, Inc. The label indicates 90 capsules per package and directs pharmacists to dispense a Medication Guide separately. It includes storage instructions, dosage advisory, manufacturer details, and a barcode with a QR code.*

FDA Label Image

Principal Display Panel (75 mg)

Pregabalin 75 mg Capsules label showing 90 capsules in the package. The label states each capsule contains 75 mg of pregabalin and includes storage instructions, child-resistant packaging warning, and pharmacist dispensing guidance. Manufactured by InvaGen Pharmaceuticals, a Cipla Ltd. subsidiary, and labeled for Cipla USA, Inc.*

FDA Label Image

Figure 1 (Pregabalincaps Fig01)

A line graph showing percent of patients improved by percent improvement in pain from baseline. It compares Pregabalin at 25 mg, 100 mg, and 200 mg taken three times a day with placebo, illustrating different improvement levels on the vertical and horizontal axes.*

FDA Label Image

Figure 2 (Pregabalincaps Fig02)

A line graph depicting the percent of patients improved versus percent improvement in pain from baseline for Pregabalin 100 mg three times a day compared to placebo. The vertical axis shows the percent of patients improved, and the horizontal axis shows the percent improvement in pain from baseline, with two lines representing Pregabalin and placebo responses.*

FDA Label Image

Figure 3 (Pregabalincaps Fig03)

A line graph showing percent of patients improved against percent improvement in pain from baseline. It compares four groups: Pregabalin 300 mg twice daily, Pregabalin 150 mg twice daily, Pregabalin 75 mg twice daily, and placebo, illustrating treatment efficacy across different dosage levels.*

FDA Label Image

Figure 4 (Pregabalincaps Fig04)

A line graph comparing the percentage of patients improved in pain from baseline on the y-axis against the percent improvement in pain from baseline on the x-axis. The graph includes three lines representing Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo, illustrating differences in pain improvement among these groups.*

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Figure 5 (Pregabalincaps Fig05)

A line graph showing the percent of patients improved plotted against percent improvement in pain from baseline. It compares Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo groups, demonstrating trends in pain improvement percentages.*

FDA Label Image

Figure 6 (Pregabalincaps Fig06)

A bar graph showing responder rates (%) in two studies (E1 and E3) for various doses of Pregabalin and placebo. Study E1 includes doses from 50 mg to 600 mg daily, with higher responder rates at increasing doses. Study E3 compares placebo, 600 mg once daily, and 600 mg three times daily doses. The x-axis shows dosage groups with sample sizes; the y-axis shows responder rates in percentage.*

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Figure 7 (Pregabalincaps Fig07)

A line graph showing seizure reduction as median percentage change from baseline on the y-axis against dose in mg/day on the x-axis. It plots data from four studies (E1 BD, E2 TID, E3 BD, E3 TID) indicating seizure reduction increases with higher doses, with significant p-values noted for dose groups compared to placebo.*

FDA Label Image

Figure 8 (Pregabalincaps Fig08)

A line graph depicting the percent of patients improved versus percent improvement in pain from baseline. It compares the effects of Pregabalin at daily doses of 800 mg, 450 mg, 300 mg, and a placebo control, showing different response curves for each treatment group across a range of pain improvement percentages.*

FDA Label Image

Figure 9 (Pregabalincaps Fig09)

A line graph comparing the estimated percentage of subjects without LTR (likely loss to follow-up or similar) over a period of 180 days between Pregabalin and Placebo groups. The solid line represents Pregabalin and shows a higher percentage of subjects without LTR over time compared to the dashed line representing Placebo.*

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Figure 11 (Pregabalincaps Fig10)

A line graph comparing the percent of subjects improved from baseline to week 12 between Pregabalin and placebo groups. The x-axis shows percent improvement ranges from 0 to 100, and the y-axis shows percent of subjects improved from 0 to 100. The solid line represents Pregabalin with higher improvement percentages across the scale, while the dashed line represents placebo with lower improvement percentages.*

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Figure 12 (Pregabalincaps Fig11)

A line chart comparing the percent of subjects improved between Pregabalin and Placebo groups. The x-axis represents percent improvement from baseline to Week 16 BOCF, while the y-axis shows the percent of subjects improved. The chart features two lines: a solid line for Pregabalin and a dashed line for Placebo, illustrating higher improvement percentages for Pregabalin across nearly all improvement levels.*

FDA Label Image

Cockcroft And Gault Equation (Pregabalincaps Formula)

A formula for creatinine clearance (CLcr) calculation using age, weight, and serum creatinine, with a multiplication factor for female patients. The formula is presented as a text panel likely from prescribing information or dosing guidelines.*

FDA Label Image

Chemical Structure (Pregabalincaps Str)

Chemical structure of pregabalin, the active ingredient shown in the image, depicting its molecular formula with distinct functional groups including amino and carboxyl 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.