Pregabalin Capsule
Product Images NDC 50268-497

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 50268-497). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avpak, 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

1 (497 01)

Packaging label for Pregabalin Capsules 25 mg by AvPAK. The label indicates 100 (10 x 10) unit-dose capsules for oral administration. It includes storage instructions, usual dosage directions referencing the prescribing information, and manufacturer details listing AvPAK and MSN Laboratories Private Limited in India. The label displays the NDC 50268-497-01 and is marked for institutional use only.*

FDA Label Image

1 (498 01)

Label for Pregabalin Capsules 50 mg by AvPAK. The Rx-only oral capsules come in unit-dose packaging with 100 capsules per carton (10x10). The label includes storage instructions, dosage information, manufacturer details, and a barcode. The design features the AvPAK logo and specifies institutional use.*

FDA Label Image

1 (499 01)

Box packaging label for Pregabalin Capsules 75 mg, a prescription oral capsule product by AvPAK. The label indicates 100 unit-dose capsules (10 x 10) and includes storage instructions, dosage reference, and manufacturer information including MSN Laboratories Private Limited in India and AvKARE/AvPAK in Pulaski, TN. The label also features the product's NDC 50268-499-01 and a barcode.*

FDA Label Image

1 (500 01)

Packaging label for Pregabalin Capsules 100 mg by AvPAK. The label indicates 100 unit-dose capsules (10 x 10) for oral use. The label states storage instructions, manufacturer details including AvPAK in Pulaski, TN, and MSN Laboratories Private Limited in Telangana, India, and includes barcodes and NDC 50268-500-01.*

FDA Label Image

1 (501 01)

Packaging label for Pregabalin Capsules 150 mg by AvPAK. The label states the dose strength of 150 mg per capsule, indicates 100 (10 x 10) unit-dose capsules per package, and notes oral route of administration. The label also includes storage instructions, manufacturer details from MSN Laboratories Private Limited in India, and AvPAK in Pulaski, TN, USA.*

FDA Label Image

1 (Table 5)

A data table presenting adverse event frequencies by body system and preferred terms for Pregabalin at 75 mg/d, 150 mg/d, 300 mg/d, and 600 mg/d doses, alongside combined Pregabalin data and placebo. Categories include infections, digestive, metabolic, musculoskeletal, nervous, respiratory, special senses, and urogenital system events with percentage values for each dosing group.*

FDA Label Image

Equation (Pregabain Gault Equation)

A mathematical formula calculating creatinine clearance (CLCr) based on age in years, weight in kilograms, serum creatinine in mg/dL, and a factor of 0.85 for female patients. This formula is typically used to assess kidney function.*

FDA Label Image

Fig-01 (Pregabalin Figure 01)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. The graph compares Pregabalin administered at 200 mg, 100 mg, and 25 mg doses three times a day with a placebo group, illustrating the distribution of pain improvement percentages among these groups.*

FDA Label Image

Fig-02 (Pregabalin Figure 02)

A line graph comparing the percent of patients improved versus percent improvement in pain from baseline, showing two groups: Pregabalin 100 mg three times a day and placebo. The x-axis represents percent improvement in pain from baseline and the y-axis represents the percent of patients improved. The Pregabalin group is represented by a dashed line consistently above the placebo dotted line across the graph.*

FDA Label Image

Fig-03 (Pregabalin Figure 03)

Kaplan-Meier style graph showing percent of patients improved versus percent improvement in pain from baseline for Pregabalin oral capsules at 75 mg, 150 mg, and 300 mg doses taken twice daily, compared to placebo. The graph depicts outcome differences across dosing with multiple lines representing each dose and placebo.*

FDA Label Image

Fig-04 (Pregabalin Figure 04)

A graph showing the percent of patients improved plotted against 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, each represented by different line styles. The x-axis indicates percent improvement in pain, and the y-axis shows the percent of patients improved.*

FDA Label Image

Fig-05 (Pregabalin Figure 05)

A line graph showing the percent of patients improved plotted against the 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 graph compares pain improvement outcomes between the two pregabalin dosages and placebo.*

FDA Label Image

Fig-06 (Pregabalin Figure 06)

A bar chart depicting responder rates (%) in two studies, E1 and E3, comparing placebo and various dosages of Pregabalin administered orally. Study E1 shows increasing responder rates from placebo to 600 mg/day with twice-daily dosing. Study E3 compares placebo, 600 mg/day twice daily, and 600 mg/day three times daily, showing higher responder rates with increased dosing frequency.*

FDA Label Image

Fig-07 (Pregabalin Figure 07)

A line graph showing seizure reduction as median percentage change from baseline, plotted against dose in mg/day. Four dosing regimens are compared: Stukly E1BID, E2BID, E3BID, and E3TID, each represented by different markers. The graph includes p-values indicating statistical significance of reductions at various doses, with dose ranging from 0 (placebo) to 600 mg/day. The y-axis measures seizure reduction percentage from 0 to 60%.*

FDA Label Image

Pregabalin-figure-08 (Pregabalin Figure 08)

A bar chart showing responder rates (%) for three groups: Placebo (22.6%), 2.5 mg/kg/day Pregabalin (29.1%), and 10 mg/kg/day Pregabalin (40.6%). The sample sizes for each group are 93, 103, and 96 respectively.*

FDA Label Image

Pregabalin-figure-09 (Pregabalin Figure 09)

A line chart showing survival or retention over time with four different curves differentiated by line style (solid, dotted, dashed, and dot-dash). The vertical axis ranges from 0 to 100, and the horizontal axis spans an unspecified time range. Two vertical reference lines mark specific points on the timeline.*

FDA Label Image

Fig-10 (Pregabalin Figure 10)

A Kaplan-Meier survival curve chart showing the estimated percentage of subjects without LTR (likely loss to response or event) over 180 days. The chart compares Pregabalin and Placebo groups, with the Pregabalin group represented by a solid line and the Placebo group by a dashed line, illustrating higher survival percentages in the Pregabalin group throughout the time course.*

FDA Label Image

Fig-11 (Pregabalin Figure 11)

A line graph comparing the percent of subjects improved over a range of percent improvement from baseline to week 12, using the baseline observation carried forward (BOCF) method. The x-axis represents the percent improved from baseline to week 12, ranging from 0 to 100 percent. The y-axis represents the percent of subjects improved, ranging from 0 to 100 percent. Two lines are shown: a solid line for Pregabalin and a dashed line for placebo, with Pregabalin consistently showing higher percent of subjects improved compared to placebo.*

FDA Label Image

Fig-12 (Pregabalin Figure 12)

A line graph comparing the percentage of subjects improved showing Pregabalin versus Placebo over a range of percent improvement from baseline to Week 16 BOCF. The x-axis represents percent improvement from baseline to Week 16, and the y-axis shows the percent of subjects improved. The graph depicts a higher percentage of improvement for Pregabalin compared to Placebo across the range.*

FDA Label Image

Str (Pregabalin Structure)

Chemical structure diagram of pregabalin showing its molecular arrangement, including amino and carboxyl functional groups and methyl side chains.*

* 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.