Pregabalin Capsule
Product Images NDC 76420-099

22 FDA label images from Asclemed Usa, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 76420-099). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Asclemed 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 (50 mg Capsule Blister Pack)

Principal Display Panel (50 mg Capsule Blister Pack)
Pregabalin Capsule 100 mg packaging labels from Enovachem Pharmaceuticals, showing two label versions for quantities of 30 and 60 capsules. The labels include NDC numbers 76420-098-30 and 76420-098-60, barcodes, and storage instructions. Manufactured by ScieGen Pharmaceuticals, Inc., the capsules are described as orange opaque.*
FDA Label Image

Principal Display Panel (50 mg Capsule Bottle Label)

Principal Display Panel (50 mg Capsule Bottle Label)
Two drug labels for Pregabalin Capsule 150 mg by Enovachem Pharmaceuticals, packaged in quantities of 30 and 60 respectively. Both labels list the NDC codes 76420-099-30 and 76420-099-60. The capsules are described as white opaque with a specified source NDC and manufactured by ScieGen Pharmaceuticals, Inc. Storage instructions and a federal law caution are also present.*
FDA Label Image

Principal Display Panel (75 mg Capsule Blister Pack)

Principal Display Panel (75 mg Capsule Blister Pack)
Packaging labels for Pregabalin Capsule 200 mg in oral capsule form, provided by Enovachem Pharmaceuticals and manufactured by ScieGen Pharmaceuticals, Inc. Two labels show package quantities of 30 and 60 capsules respectively. Labels include NDC numbers 76420-100-30 and 76420-100-60, lot and batch numbers, expiration date fields, and controlled substance status (CV). Storage instructions and dispensing cautions are also visible.*
FDA Label Image

Principal Display Panel (75 mg Capsule Blister Pack)

Principal Display Panel (75 mg Capsule Blister Pack)
Two drug packaging labels for Pregabalin Capsule 225 mg from Enovachem Pharmaceuticals, packaged in quantities of 30 and 60 capsules. Each label includes NDC codes (76420-101-30 and 76420-101-60), manufacturer ScieGen Pharmaceuticals, Inc., and physical description of the capsules as light orange and white opaque. Storage and dispensing cautions are also present.*
FDA Label Image

Principal Display Panel (25 mg Capsule Bottle)

Principal Display Panel (25 mg Capsule Bottle)
Labels for Pregabalin Capsule 25 mg by Enovachem Pharmaceuticals, showing two NDCs: 76420-095-30 for a quantity of 30 capsules and 76420-095-60 for a quantity of 60 capsules. Manufactured by ScieGen Pharmaceuticals, Inc., the capsules are described as white opaque. Labels include storage instructions and federal law cautions.*
FDA Label Image

Principal Display Panel (75 mg Capsule Blister Pack Carton)

Principal Display Panel (75 mg Capsule Blister Pack Carton)
Two packaging labels for Pregabalin Capsule 300 mg by Enovachem Pharmaceuticals, showing different package quantities of 30 and 60 capsules respectively. Each label includes NDC numbers 76420-102-30 and 76420-102-60, manufacturing by ScieGen Pharmaceuticals, Inc., and storage instructions to keep at 20-25°C. Labels have a barcode and caution about dispensing with prescription.*
FDA Label Image

Principal Display Panel (25 mg Capsule Blister Pack)

Principal Display Panel (25 mg Capsule Blister Pack)
Packaging labels for Pregabalin Capsule 50 mg in capsule form by Asclemed USA, Inc. Two labels shown: one for a quantity of 30 capsules with NDC 76420-096-30, and one for a quantity of 60 capsules with NDC 76420-096-60. Both labels include manufacturer ScieGen Pharmaceuticals, Inc., packaging by Enovachem Pharmaceuticals, batch and lot placeholders, storage instructions, and cautionary statements.*
FDA Label Image

Principal Display Panel (50 mg Capsule Blister Pack Carton)

Principal Display Panel (50 mg Capsule Blister Pack Carton)
Two drug packaging labels for Pregabalin Capsule 75 mg by Enovachem Pharmaceuticals. Each label shows the product name, dosage strength, NDC (76420-097-30 and 76420-097-60), quantity (30 and 60 capsules), and manufacturer ScieGen Pharmaceuticals, Inc. The labels include storage instructions, barcode, batch and lot info, and the drug status as CV (controlled substance).*
FDA Label Image

Principal Display Panel (25 mg Capsule Bottle Label)

Principal Display Panel (25 mg Capsule Bottle Label)
Labels for Pregabalin Capsules in multiple strengths including 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg. Each label shows a 90-count package and identifies Enovachem Pharmaceuticals as the relabeler and ScieGen Pharmaceuticals, Inc. as the manufacturer. Capsules are described with color variations such as white opaque and orange opaque. Each label includes an NDC, barcode, and storage instructions.*
FDA Label Image

Figure 1 (Pregabalin Fig01)

Figure 1 (Pregabalin Fig01)
A line graph showing the percent of patients improved on the y-axis versus percent improvement in pain from baseline on the x-axis for Pregabalin capsules in 25 mg, 100 mg, and 200 mg doses taken three times a day compared to placebo. The graph demonstrates variation in patient improvement by dosage over a range of pain improvement percentages.*
FDA Label Image

Figure 2 (Pregabalin Fig02)

Figure 2 (Pregabalin Fig02)
A line graph depicting the percent of patients improved versus percent improvement in pain from baseline for Pregabalin 100 mg taken three times daily compared to placebo. The graph shows that a higher percentage of patients taking Pregabalin experienced greater pain improvement than those on placebo, with vertical lines highlighting thresholds of pain improvement.*
FDA Label Image

Figure 3 (Pregabalin Fig03)

Figure 3 (Pregabalin Fig03)
A line graph showing the percent of patients improved on the y-axis versus percent improvement in pain from baseline on the x-axis. The graph compares Pregabalin at 300 mg, 150 mg, and 75 mg dosed twice daily with placebo, demonstrating varying levels of pain improvement for each group.*
FDA Label Image

Figure 4 (Pregabalin Fig04)

Figure 4 (Pregabalin Fig04)
A line graph 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 shows percent of patients improved, and the horizontal axis shows percent improvement in pain, with three lines representing the treatment groups across the pain improvement spectrum.*
FDA Label Image

Figure 5 (Pregabalin Fig05)

Figure 5 (Pregabalin Fig05)
A line graph showing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo. The graph compares the efficacy of two doses of Pregabalin against placebo in pain improvement.*
FDA Label Image

Figure 6 (Pregabalin Fig06)

Figure 6 (Pregabalin Fig06)
A bar chart comparing responder rates (%) for Pregabalin doses versus placebo in two clinical studies labeled Study E1 and Study E3. The chart shows increasing responder rates with higher doses of Pregabalin, with statistical significance indicated for most dose groups compared to placebo. Study E1 includes doses from 50 mg/day to 600 mg/day with twice-daily (BID) administration, while Study E3 shows doses of 300 mg/day and 600 mg/day with BID and three-times-daily (TID) dosing, respectively.*
FDA Label Image

Figure 7 (Pregabalin Fig07)

Figure 7 (Pregabalin Fig07)
A line graph depicting seizure reduction as median percent change from baseline versus pregabalin dose in mg/day. It compares results from four studies (E1 BD, E2 TID, E3 BD, and E3 TID) with significant p-values noted. The x-axis shows dose from 0 to 600 mg/day, and the y-axis shows seizure reduction up to 60%.*
FDA Label Image

Figure 9 (Pregabalin Fig08)

Figure 9 (Pregabalin Fig08)
A line graph showing the percentage of patients improved versus percent improvement in pain from baseline comparing Pregabalin at 800 mg, 450 mg, 300 mg daily doses, and placebo. The x-axis represents percent improvement in pain from baseline ranging from 0 to 100, and the y-axis shows the percent of patients improved, ranging from 0 to 100. Different line styles distinguish the treatment groups, with Pregabalin 800 mg daily dose showing higher improvement than lower doses and placebo.*
FDA Label Image

Figure 10 (Pregabalin Fig09)

Figure 10 (Pregabalin Fig09)
A line graph comparing the estimated percentage of subjects without LTR (loss to response) over 180 days between Pregabalin and placebo groups. The y-axis shows the estimated percentage of subjects without LTR from 0% to 100%, and the x-axis represents days from 0 to 180. The Pregabalin group shows a higher percentage of subjects without LTR over time compared to the placebo group.*
FDA Label Image

Figure 11 (Pregabalin Fig10)

Figure 11 (Pregabalin Fig10)
A line graph comparing the percent of subjects improved over a range of percentage improvements from baseline to Week 12 between Pregabalin and placebo groups. The x-axis represents percent improvement, while the y-axis shows the percent of subjects improved. Pregabalin data is shown with a solid line and placebo data with a dashed line, illustrating a higher percentage of subjects improved with Pregabalin across the improvement range.*
FDA Label Image

Figure 12 (Pregabalin Fig11)

Figure 12 (Pregabalin Fig11)
A line graph showing the percent of subjects improved on the vertical axis versus percent improvement from baseline to week 16 on the horizontal axis, comparing Pregabalin (solid line) with Placebo (dashed line). The graph illustrates the distribution of improvement levels among subjects over time.*
FDA Label Image

Cockcroft And Gault Equation (Pregabalin Formula)

Cockcroft And Gault Equation (Pregabalin Formula)
A text panel displaying a formula to calculate creatinine clearance (CLcr) based on age, weight, and serum creatinine, with an adjustment factor for female patients. The formula is relevant for assessing kidney function.*
FDA Label Image

Chemical Structure (Pregabalin Str)

Chemical Structure (Pregabalin Str)
Chemical structure of pregabalin, showing its molecular arrangement with characteristic functional groups including amine (NH2) and carboxylic acid (CO2H) moieties.*

* 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.