Pregabalin Capsule
Product Images NDC 27808-240

20 FDA label images from Tris Pharma Inc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 27808-240). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Tris Pharma 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

Pregabalin-equation (Pregabalin Capsules 1)

Pregabalin-equation (Pregabalin Capsules 1)
A mathematical formula depicting the calculation of creatinine clearance (CLCr) based on age, weight, and serum creatinine levels, with an adjustment factor for female patients.*
FDA Label Image

Figure 9 (Pregabalin Capsules 10)

Figure 9 (Pregabalin Capsules 10)
A line graph showing the percent of patients improved by percent improvement in pain from baseline for Pregabalin and placebo groups. Four lines represent Pregabalin at 600 mg, 450 mg, 300 mg daily doses, and placebo. The x-axis indicates percent improvement in pain from 0 to 100%, and the y-axis shows the percent of patients improved from 0 to 100%. Vertical lines highlight thresholds at 30% and 50% improvement.*
FDA Label Image

Figure 10 (Pregabalin Capsules 11)

Figure 10 (Pregabalin Capsules 11)
A Kaplan-Meier survival curve chart comparing the estimated percentage of subjects without LTR over 180 days between Pregabalin and placebo groups. The x-axis represents days, and the y-axis represents the estimated percentage of subjects without LTR, showing a higher survival rate in the Pregabalin group compared to placebo over time.*
FDA Label Image

Figure 11 (Pregabalin Capsules 12)

Figure 11 (Pregabalin Capsules 12)
A line graph comparing the percent of subjects improved over the percent improved from baseline to week 12 BOCF for Pregabalin versus Placebo. The x-axis represents the percent improved from baseline (ranging from 0 to 100%), and the y-axis shows the percent of subjects improved (from 0 to 100%). Two lines indicate the improvement trends for Pregabalin (solid line) and Placebo (dashed line).*
FDA Label Image

Figure 12 (Pregabalin Capsules 13)

Figure 12 (Pregabalin Capsules 13)
A line graph comparing the percent of subjects improved over time from baseline to week 16, detailing results for Pregabalin versus Placebo. The x-axis shows percent improved, while the y-axis represents percentage of subjects. Two curves track improvement for Pregabalin and Placebo groups.*
FDA Label Image

50 mg_90 Capsules (Pregabalin Capsules 14)

50 mg_90 Capsules (Pregabalin Capsules 14)
Label for Pregabalin Capsules 50 mg by Tris Pharma Inc. The label states the dosage strength as 50 mg per capsule and the package contains 90 capsules. It includes storage instructions and manufacturer information, listing Changzhou Pharmaceutical Factory, China, as the manufacturer and Tris Pharma, Inc. as the distributor. The label also notes Rx only status and references an enclosed Medication Guide.*
FDA Label Image

75 mL_90 Capsules (Pregabalin Capsules 15)

75 mL_90 Capsules (Pregabalin Capsules 15)
Label for Pregabalin Capsules 75 mg by Tris Pharma Inc. The label states the dosage strength as 75 mg per capsule, with 90 capsules per container. It includes storage instructions (store at 25°C, excursions permitted to 15-30°C), dispensing in child-resistant containers, and manufacturing details for Changzhou Pharmaceutical Factory, China. The label shows the NDC number 27808-236-01 and a barcode.*
FDA Label Image

100 mg_90 Capsules (Pregabalin Capsules 16)

100 mg_90 Capsules (Pregabalin Capsules 16)
Label for Pregabalin Capsules 100 mg by Tris Pharma Inc. The label includes the NDC 27808-237-01, states that each capsule contains 100 mg of pregabalin, and that the package contains 90 capsules. Storage instructions specify 25°C (77°F) with permitted excursions. It notes dispensing in child-resistant containers and includes manufacturer and distributor information.*
FDA Label Image

150 mg_90 Capsules (Pregabalin Capsules 17)

150 mg_90 Capsules (Pregabalin Capsules 17)
Label for Pregabalin Capsules 150 mg, oral dosage form by Tris Pharma Inc. The label includes storage instructions at 25°C with permitted excursions and specifies child-resistant containers. It indicates that 90 capsules are contained and provides manufacturer and distributor information with a barcode on the right.*
FDA Label Image

200 mg_90 Capsules (Pregabalin Capsules 18)

200 mg_90 Capsules (Pregabalin Capsules 18)
Label for Pregabalin Capsules 200 mg by Tris Pharma Inc. The label includes storage instructions at 25°C with allowed excursions, child-resistant container dispensing, and directs to dispense the enclosed medication guide. It lists the manufacturer as Changzhou Pharmaceutical Factory in China and distributor as Tris Pharma in New Jersey, USA. The package contains 90 capsules.*
FDA Label Image

225 mg_90 Capsules (Pregabalin Capsules 19)

225 mg_90 Capsules (Pregabalin Capsules 19)
Label for Pregabalin Capsules 225 mg by Tris Pharma Inc. The capsule count is 90, and the label includes storage instructions at 25°C (77°F) with permitted excursions. The product is manufactured by Changzhou Pharmaceutical Factory in China and distributed by Tris Pharma in the USA. It is Rx only and includes a barcode.*
FDA Label Image

Structure (Pregabalin Capsules 2)

Structure (Pregabalin Capsules 2)
Chemical structure diagram of Pregabalin, showing the molecular arrangement including functional groups carboxylic acid (CO2H) and amine (NH2).*
FDA Label Image

300 mg_90 Capsules (Pregabalin Capsules 20)

300 mg_90 Capsules (Pregabalin Capsules 20)
Label for Pregabalin Capsules 300 mg by Tris Pharma Inc. The label indicates the product contains 90 capsules, each with 300 mg pregabalin. Storage instructions specify 25°C (77°F) with permitted excursions to 15-30°C. It advises dispensing in child-resistant containers. Manufactured by Changzhou Pharmaceutical Factory in China and distributed by Tris Pharma, New Jersey, USA.*
FDA Label Image

Figure 1 (Pregabalin Capsules 3)

Figure 1 (Pregabalin Capsules 3)
A line graph depicting percent improvement in pain from baseline on the x-axis against the percent of patients improved on the y-axis. The graph compares four lines representing Pregabalin dosed at 200 mg, 100 mg, and 25 mg three times a day, as well as a placebo group. Percent of patients improved decreases with increasing pain improvement thresholds across all groups.*
FDA Label Image

Figure 2 (Pregabalin Capsules 4)

Figure 2 (Pregabalin Capsules 4)
A line graph comparing the percent of patients improved by percent improvement in pain from baseline, showing two curves for Pregabalin 100 mg three times a day and placebo. The x-axis represents percent improvement in pain, while the y-axis shows the percent of patients improved. Vertical lines are drawn at 30% and 50% improvement levels.*
FDA Label Image

Figure 3 (Pregabalin Capsules 5)

Figure 3 (Pregabalin Capsules 5)
A line graph depicting the percent of patients improved relative to the percent improvement in pain from baseline. It compares Pregabalin capsules at doses of 75 mg, 150 mg, and 300 mg taken three times a day versus placebo, showing increasing patient improvement with higher doses of Pregabalin.*
FDA Label Image

Figure 4 (Pregabalin Capsules 6)

Figure 4 (Pregabalin Capsules 6)
A line graph comparing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin 100 mg and 200 mg taken three times a day, and placebo. The graph displays three lines showing patient improvement trends for each treatment group.*
FDA Label Image

Figure 5 (Pregabalin Capsules 7)

Figure 5 (Pregabalin Capsules 7)
A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline for Pregabalin 50 mg and 100 mg taken three times a day, and placebo. The x-axis shows percent improvement in pain, and the y-axis shows the percent of patients improved, with data indicating higher improvement rates for Pregabalin doses compared to placebo.*
FDA Label Image

Figure 6 (Pregabalin Capsules 8)

Figure 6 (Pregabalin Capsules 8)
A bar graph comparing responder rates (%) for Pregabalin in two studies (E1 and E3). The x-axis lists doses including placebo and various Pregabalin doses (mg/day), while the y-axis shows responder rates from 0% to 60%. Study E1 shows increasing responder rates with rising doses up to 51% at 600 mg/day BID. Study E3 shows responder rates of 9% for placebo, rising to 49% at 600 mg/day TID.*
FDA Label Image

Figure 7 (Pregabalin Capsules 9)

Figure 7 (Pregabalin Capsules 9)
A dose-response graph showing seizure reduction as median percentage change from baseline on the y-axis and dose in mg/day on the x-axis. The chart compares four study groups with different dosing schedules (BID or TID) represented by different symbols, with p-values indicating statistical significance for the reductions observed at various doses.*

* 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.