Pregabalin Capsules, Cv Capsule
Product Images NDC 69097-685

Product Visual Gallery

This gallery contains 30 technical images submitted to the FDA as part of the official labeling for Pregabalin Capsules, Cv (NDC 69097-685). 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

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.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 02

Chemical structure of pregabalin, the active ingredient in PREGABALIN capsules, CV, showing its molecular arrangement with a carboxyl group, amine group, and hydrocarbon backbone.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 03

A line graph showing percent of patients improved on the y-axis against percent improvement in pain from baseline on the x-axis. The graph compares Pregabalin capsules, CV at doses of 25 mg and 200 mg taken three times a day, and a placebo, illustrating differences in pain improvement over a range.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 04

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline for Pregabalin 100 mg three times a day and placebo. The x-axis represents percent improvement in pain, and the y-axis shows the percent of patients improved. The graph depicts higher improvement rates for Pregabalin over placebo.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 05

A line graph showing the percent of patients improved plotted against the percent improvement in pain from baseline for Pregabalin 75 mg, 150 mg, and 300 mg taken twice a day, compared to placebo. The graph illustrates comparative efficacy trends of different Pregabalin doses versus placebo over a range of pain improvement percentages.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 06

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, with performance trends for each across increasing pain improvement percentages.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 07

A line graph depicting the percent of patients improved relative to percent improvement in pain from baseline for three groups: Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo. The x-axis shows percent improvement in pain, and the y-axis shows the percent of patients improved. The graph compares effectiveness across different percentages of pain improvement for each group.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 08

A bar chart showing responder rates (%) for Pregabalin and placebo in two studies, Study E1 and Study E3. The x-axis lists placebo and varying doses of Pregabalin (50 mg/day, 150 mg/day, 300 mg/day, 600 mg/day for Study E1; 8 mg, 8 TID, 300 mg/day for Study E3). The y-axis shows response rates from 0% to 60%. Study E1 shows increasing responder rates with higher doses compared to placebo, with statistically significant differences marked. Study E3 compares placebo and two Pregabalin doses with higher response rates at 300 mg/day.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 09

A line graph depicting seizure reduction as median percent change from baseline plotted against daily dose (mg/day) of pregabalin. The graph includes four data series from different studies, identified by distinct markers, showing increasing seizure reduction with higher doses. Significant p-values are noted for marked data points.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 10

A bar graph showing responder rates in percentage for three groups: Placebo (22.6%, N=93), 2.5 mg/kg/day dosage (29.1%, N=103), and 10 mg/kg/day dosage (40.6%, N=96). The y-axis represents responder rate in percentage, and the x-axis represents the treatment groups.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 11

A line graph showing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin capsules, CV at daily doses of 300 mg, 450 mg, and 600 mg compared to placebo. The graph depicts the efficacy trend of increasing pain improvement with higher doses against placebo across the x-axis ranging from 0 to 100 percent improvement.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 12

A Kaplan-Meier survival curve chart comparing the estimated percentage of subjects without LTR (loss to retention) over 180 days between Pregabalin and placebo groups, showing a higher percentage of subjects without LTR in the placebo group than in the Pregabalin group.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 13

A line graph comparing the percent of subjects improved from baseline to week 12 in a clinical study of Pregabalin capsules versus placebo. The x-axis shows the percent improvement, the y-axis shows the percent of subjects improved. Two lines represent Pregabalin and placebo, illustrating greater improvement with Pregabalin across the range.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 14

A line graph comparing the percent of subjects improved from baseline to Week 16 BOCF between Pregabalin and Placebo groups. The x-axis represents percent improved from baseline to Week 16 BOCF, and the y-axis represents the percent of subjects improved, showing higher improvement in the Pregabalin group compared to Placebo across the range.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 15

Label panel for Pregabalin Capsules CV 25 mg by Cipla USA Inc. The label includes storage instructions, pharmacist dispensing guidance, packaging quantity of 100 capsules, and manufacturer details (Cipla Ltd., Kurkumbh, India). It indicates the product is for oral use and prescription only.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 16

Label for Pregabalin capsules, CV, 25 mg strength, supplied by Cipla USA Inc. The label includes storage instructions, dispensing guidelines, and identifies the capsules as prescription-only. The package contains 90 capsules and includes manufacturer information for Cipla Ltd., India, with commercial address in Warren, NJ. A barcode and area for batch overprinting of serial number, expiry, and lot details are also present.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 17

Packaging label for Pregabalin Capsules 50 mg by Cipla USA Inc. The label specifies prescription-only status and instructs to dispense the Medication Guide provided separately. The label includes storage instructions, dosage warnings, and manufacturer information. The package contains 100 capsules (10 x 10 unit-dose).*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 18

Label for Pregabalin Capsules 50 mg by Cipla USA Inc. The label indicates prescription-only status and includes dosing and storage instructions. It states each capsule contains 50 mg of Pregabalin. The package contains 90 capsules. The label also shows a barcode, QR code, and space for batch overprinting of serial number, expiry, and lot information.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 19

Label for Pregabalin capsules, 75 mg, from Cipla USA Inc. The label includes dosage instructions, storage conditions at 25°C, child safety warnings, and states that each capsule contains 75 mg of Pregabalin USP. Packaging is for 100 oral capsules in 10-unit doses. It has the NDC code 69097-679-21 and indicates the product is prescription only.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 20

Label for Pregabalin Capsules, CV, 75 mg strength by Cipla USA Inc. The label includes NDC 69097-679-05, pharmacist instructions to dispense the Medication Guide, and storage information. It indicates 90 capsules per container and shows batch information placeholders for serial number, expiry date, and lot number. The manufacturer is Cipla Ltd., Kurkumbh, India, with the labeler address in Warren, NJ.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 21

Packaging label for Pregabalin Capsules 100 mg by Cipla USA Inc. The label states 100 capsules per container, with the instruction to see the Medication Guide provided separately. Storage instructions specify 25°C (77°F) with permitted excursions between 15°-30°C (59°-86°F). The label includes the NDC number 0598-681-21 and mentions the product is Rx Only. Manufacturer information lists Cipla Ltd., India, and Cipla USA, NJ.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 22

Label for Pregabalin Capsules CV 100 mg by Cipla USA Inc. The label states 90 capsules per container, intended for oral use. It includes storage instructions, manufacturer details, dosage information, and a barcode. It also has a designated area for batch overprinting with serial number, expiration, and lot information.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 23

The packaging label for Pregabalin Capsules 150 mg, manufactured by Cipla USA Inc., indicates an oral dosage form. The label includes storage instructions, a note to dispense the Medication Guide with each patient, and states each capsule contains 150 mg Pregabalin USP. The package holds 100 capsules (10 x 10 count). Additional details include manufacturer information and NDC 0591-682-21.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 24

Label for Pregabalin Capsules 150 mg by Cipla USA Inc. The label indicates 90 capsules per bottle with prescription use only. It includes storage instructions, manufacturer details (Cipla Ltd., Kurkumbh, India), and barcode. The label notes the need to dispense a medication guide to patients and mentions batch overprinting for serial number, expiry, and lot during commercial packing.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 25

Pregabalin Capsules 200 mg packaging label from Cipla USA Inc. The label indicates the product is for oral use with 100 capsules per container (10 x 10 unit dose). It includes storage instructions to keep at 25°C with allowed excursions and warnings to keep out of reach of children. The label indicates it is a prescription medicine with dosage information, manufacturer details, and barcode present.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 26

Label for Pregabalin Capsules, CV, 200 mg, by Cipla USA Inc. The label indicates 90 capsules and includes storage instructions at 25°C with allowed excursions. It notes the medication guide for patients and manufacturing by Cipla Ltd., Kurkumbh, India. The label also has a barcode and a designated area for batch overprinting including serial number, expiry, and lot details.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 27

Packaging label for Pregabalin Capsules, 225 mg, by Cipla USA Inc. The label indicates 100 capsules per bottle (10 x 10 unit dose) for oral use. Storage instructions specify 25°C (77°F) with permitted excursions and child-resistant packaging. The label includes NDC 59097-684-21, manufacturer and distributor details, and dosage and use instructions mention each capsule contains 225 mg Pregabalin USP.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 28

Label for Pregabalin Capsules 225 mg by Cipla USA Inc. The label includes dosing and storage instructions, a barcode, and indicates 90 capsules per package. It notes manufacturing by Cipla Ltd., Kurkumbh, India, and directs pharmacists to dispense the accompanying Medication Guide. The batch information area is reserved for serial number, expiry, and lot numbers.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 29

Label for Pregabalin capsules, 300 mg strength, in a carton package. The label states the product name, dosage form, and strength prominently on the front and sides. It includes storage instructions, packaging size of 100 capsules (10 x 10 unit dose), manufacturer Cipla USA Inc., and other regulatory information. The label design features a blue stripe and purple highlighted dosage strength.*

FDA Label Image

03a1965c 9956 486f 8599 7f5ecbf6c3b5 30

Pregabalin Capsules 300 mg label for a package of 90 oral capsules by Cipla USA Inc. The label includes storage instructions (store at 25°C, excursions permitted to 15-30°C), dispensing guidance, manufacturer details, and areas for batch overprinting with serial number, expiry date, and lot number. The label features a barcode and the NDC 69097-685-05.*

* 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.