Levetiracetam Tablet, Film Coated
Product Images NDC 43547-880

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Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Levetiracetam (NDC 43547-880). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Solco Healthcare Us, Llc, 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

Figure 2: Responder Rate (≥50% Reduction From Baseline) In Study 2: Period A (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 02)

Figure 2: Responder Rate (≥50% Reduction From Baseline) In Study 2: Period A (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 02)
An illustration showing the formula to estimate creatinine clearance (CLcr), which uses parameters including age (years), weight (kg), serum creatinine (mg/dL), and an adjustment factor of 0.85 for female patients.*
FDA Label Image

Figure 3: Responder Rate (≥50% Reduction From Baseline) In Study 3 (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 03)

Figure 3: Responder Rate (≥50% Reduction From Baseline) In Study 3 (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 03)
An equation describing creatinine clearance (CLcr) normalized for body surface area, presenting CLcr per mL per minute per 1.73 m² as a function of subject's CLcr and body surface area. This is a pharmacokinetic-related formula.*
FDA Label Image

Levetiracetam Structural Formula (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 04)

Levetiracetam Structural Formula (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 04)
Chemical structure of Levetiracetam, showing its molecular formula with rings and side chains representative of the compound's active ingredient.*
FDA Label Image

Figure 1: Responder Rate (greater Than Or Equal To 50% Reduction From Baseline) In Study 1 (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 05)

Figure 1: Responder Rate (greater Than Or Equal To 50% Reduction From Baseline) In Study 1 (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 05)
A bar chart titled 'Responder Rate (>50% Reduction From Baseline) In Study 1' comparing the percentage of patients responding to placebo and two doses of Levetiracetam tablets: 1000 mg/day and 3000 mg/day. The y-axis shows the percentage of patients, with placebo at 7.4%, Levetiracetam 1000 mg/day at 37.1%, and Levetiracetam 3000 mg/day at 39.6%. A note indicates statistically significant differences versus placebo.*
FDA Label Image

Figure 3: Responder Rate (≥50% Reduction From Baseline) In Study 3 (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 06)

Figure 3: Responder Rate (≥50% Reduction From Baseline) In Study 3 (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 06)
Bar chart showing responder rates defined as at least 50% reduction from baseline in Study 2 during Period A. The chart compares placebo with Levetiracetam 1000 mg/day and 2000 mg/day tablets. Responder rates are approximately 6.3% for placebo, 20.8% for 1000 mg/day, and 35.2% for 2000 mg/day doses, with statistically significant differences versus placebo indicated.*
FDA Label Image

Figure 3: Responder Rate (greater Than Or Equal To 50% Reduction From Baseline) In Study 3 (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 07)

Figure 3: Responder Rate (greater Than Or Equal To 50% Reduction From Baseline) In Study 3 (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 07)
A bar chart titled 'Responder Rate (>50% Reduction From Baseline) In Study 3' comparing placebo versus Levetiracetam 3000 mg/day. The y-axis shows the percentage of patients ranging from 0% to 45%. The placebo group (N=104) shows a responder rate of 14.4%, while the Levetiracetam group (N=180) shows a higher responder rate of 39.4%, marked as statistically significant versus placebo.*
FDA Label Image

Figure 4: Responder Rate (greater Than Or Equal To 50% Reduction From Baseline) (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 08)

Figure 4: Responder Rate (greater Than Or Equal To 50% Reduction From Baseline) (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 08)
A bar chart showing the responder rate of patients achieving 50% or greater reduction from baseline in Study 4. The chart compares placebo with Levetiracetam, indicating about 19.6% responder rate for placebo (N=97) and 44.6% for Levetiracetam (N=101), with a note of statistical significance versus placebo.*
FDA Label Image

Figure 5 (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 09)

Figure 5 (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 09)
A bar chart comparing the percentage of patients in two groups: placebo (51 patients) and Levetiracetam (58 patients). The placebo group shows 19.6% of patients, while the Levetiracetam group shows 43.1%, with an asterisk indicating statistical significance versus placebo. The y-axis is labeled as percentage of patients, ranging from 0% to 45%.*
FDA Label Image

Figure 6: Responder Rate (greater Than Or Equal To 50% Reduction From Baseline) In Pgtc Seizure Frequency Per Week (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 10)

Figure 6: Responder Rate (greater Than Or Equal To 50% Reduction From Baseline) In Pgtc Seizure Frequency Per Week (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 10)
A bar graph showing the responder rate (% of patients with ≥50% reduction in PGTC seizure frequency per week) comparing placebo and Levetiracetam in Study 7. The placebo group (N=84) had a responder rate of 45.2%, while the Levetiracetam group (N=79) had a higher responder rate of 72.2%, noted as statistically significant versus placebo.*
FDA Label Image

250 mg 120 Ct (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 11)

250 mg 120 Ct (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 11)
Levetiracetam Tablets, USP 250 mg film-coated oral tablets label showing the NDC 43547-880-15. The label indicates a package containing 120 tablets, manufactured by Prinston Laboratories and distributed by Solco Healthcare US, LLC. Storage instructions and a medication guide URL are included. The label also notes a no coat tablet size of 2.00" x 0.75".*
FDA Label Image

500 mg 120 Ct (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 12)

500 mg 120 Ct (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 12)
Label for Levetiracetam Tablets, USP 500 mg film-coated tablets. The label includes storage instructions, manufacturer Prinston Laboratories, and distributor Solco Healthcare US, LLC. The package contains 120 tablets and includes a pharmacist dispensing note. The tablet image shows an oval pink tablet with the imprint visible. The label also states 'No Coat 2.00"x0.75" and a barcode.*
FDA Label Image

750 mg 120 Ct (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 13)

750 mg 120 Ct (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 13)
Levetiracetam Tablets USP 750 mg film-coated oral tablets label showing a count of 120 tablets. The label includes storage instructions, manufacturer Prinston Laboratories in Charlotte, NC, and distributor Solco Healthcare US, LLC. It features a blue background with bold product name and strength.*
FDA Label Image

1000 mg 60 Ct (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 14)

1000 mg 60 Ct (F7b86151 8fdf 4bb8 8cd6 E6e24786df64 14)
Levetiracetam Tablets USP 1,000 mg film-coated oral tablets label showing product name, strength, package size of 60 tablets, and manufacturer information. Instructions include dispensing in a tight, light resistant container with a child-resistant closure. Labeler is Solco Healthcare US, LLC, with manufacturing by Prinston Laboratories. A barcode and storage temperature guidance are also visible.*
FDA Label Image

Trademark (Image 01)

* 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.