Pregabalin
Product Images NDC 50436-0325

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 50436-0325). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Services, 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

Label Image (Lbl504360325)

Pregabalin 50 mg capsule label by Unit Dose Services. The label states each capsule contains 50 mg pregabalin, in child-resistant containers. It includes storage instructions to keep at 25°C (77°F) in a controlled room temperature, a warning to keep out of reach of children, and packaging info for 30 capsules. Manufacturer is SciGen Pharmaceuticals Inc., Hauppauge, NY. Multiple NDC numbers and placeholders for lot and expiration dates are present.*

FDA Label Image

Label Image (Lbl504360326)

Pregabalin 75 mg capsules packaging label from Unit Dose Services. The label includes NDC 50436-0326-1, specifying a package of 30 capsules containing 75 mg pregabalin each. It displays manufacturer details for Sciegen Pharmaceuticals, Inc., located in Hauppauge, NY, with associated lot, expiration, and serial number fields. The label notes the drug is for prescription use only and advises storage at controlled room temperature.*

FDA Label Image

Chemical Structure (Pregabalin 01)

Chemical structure of pregabalin showing its molecular framework including the isobutyl group, an amino group (NH2), and a carboxyl group (CO2H). This structural diagram depicts the arrangement of atoms and bonds within the pregabalin molecule.*

FDA Label Image

Figure 1 (Pregabalin 02)

A line graph illustrating the percent of patients improved versus percent improvement in pain from baseline. It compares Pregabalin at doses of 200 mg, 100 mg, and 25 mg three times a day, alongside a placebo group. The vertical axis shows patient improvement percentage, and the horizontal axis shows percentage improvement in pain, with markers at intervals such as 30% and 50% improvement.*

FDA Label Image

Figure 2 (Pregabalin 03)

A line graph comparing the percent of patients improved versus percent improvement in pain from baseline. It shows two lines: one for Pregabalin 100 mg three times a day and one for a placebo, with Pregabalin generally showing a higher percent of patients improved across pain improvement levels.*

FDA Label Image

Figure 3 (Pregabalin 04)

This line graph shows the percent of patients improved versus percent improvement in pain from baseline for Pregabalin at doses of 75 mg, 150 mg, and 300 mg taken twice a day, compared to placebo. The graph illustrates a dose-dependent increase in pain improvement percentages among patients treated with Pregabalin relative to placebo.*

FDA Label Image

Figure 4 (Pregabalin 05)

A line chart comparing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo. The vertical axis represents the percent of patients improved from 0 to 100, and the horizontal axis shows percent improvement in pain from baseline from 0 to 100. Three lines represent the different groups with varying trends in improvement.*

FDA Label Image

Figure 5 (Pregabalin 06)

A line graph comparing the percent improvement in pain from baseline versus the percent of patients improved for Pregabalin 50 mg three times a day, Pregabalin 100 mg three times a day, and placebo. The graph shows higher percentages of patients improved with Pregabalin compared to placebo across increasing pain improvement levels.*

FDA Label Image

Figure 6 (Pregabalin 07)

Bar graph comparing responder rates (%) in two clinical studies, Study E1 and Study E3, for Pregabalin doses versus placebo. The x-axis lists doses and placebo groups, with responder rates on the y-axis. Study E1 shows increasing responder rates with Pregabalin doses 50 mg/day to 600 mg/day. Study E3 shows responder rates for 300 mg/day and 600 mg/day doses against placebo.*

FDA Label Image

Figure 7 (Pregabalin 08)

A line graph depicting seizure reduction as median percent change from baseline versus dose in mg/day for Pregabalin. It compares four study groups (E1 BID, E2 TID, E3 BID, E3 TID) with distinct markers, displaying upward trends in seizure reduction with increasing dose. Significant p-values are indicated at various dose points, highlighting statistical significance. The graph notes that dose 0 corresponds to placebo.*

FDA Label Image

Figure 9 (Pregabalin 09)

A Kaplan-Meier curve comparing percent of patients improved versus percent improvement in pain from baseline. The chart includes four lines representing Pregabalin dosed at 300 mg, 450 mg, and 600 mg daily, as well as a placebo group. The x-axis shows percent improvement in pain, and the y-axis indicates percent of patients improved.*

FDA Label Image

Figure 10 (Pregabalin 10)

A Kaplan-Meier survival curve comparing the estimated percentage of subjects without LTR (loss to remission or response) over 180 days between Pregabalin and placebo groups. The y-axis represents the percentage of subjects without LTR, the x-axis shows days, with solid and dashed lines for Pregabalin and placebo, respectively. The Pregabalin group shows a higher percentage of subjects without LTR over time compared to placebo.*

FDA Label Image

Figure 11 (Pregabalin 11)

A line graph comparing the percentage of subjects improved over time from baseline to week 12 between Pregabalin and placebo groups. The horizontal axis represents the percent improved from baseline to week 12 using BOCF, and the vertical axis shows the percent of subjects improved. Two lines depict the Pregabalin group (solid line) and the placebo group (dotted line).*

FDA Label Image

Figure 12 (Pregabalin 12)

A line graph comparing the percent of subjects improved over weeks between Pregabalin and Placebo groups. The x-axis represents percent improvement from baseline to Week 16 BOCF, ranging from >0 to 100. The y-axis shows the percent of subjects improved, ranging from 0 to 100 percent. Two lines depict outcomes: a solid line for Pregabalin and a dashed line for Placebo, illustrating comparative improvement over time.*

* 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.