Levetiracetam Tablet, Film Coated
Product Images NDC 0378-5615

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Levetiracetam (NDC 0378-5615). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Pharmaceuticals 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

Export 00

Levetiracetam 1000 mg tablets, USP, oral film-coated tablets by Mylan Pharmaceuticals Inc. The label shows the dosage strength 1000 mg, a supply of 60 tablets, and NDC 0378-5619-91. It includes usage instructions to dispense medication guides and storage conditions (20° to 25°C). The label is marked Rx only and features a barcode and Mylan logo.*

FDA Label Image

Export 01

Levetiracetam 750 mg film-coated tablets in an oral dosage form, labeled for prescription use by Mylan Pharmaceuticals Inc. The label includes dosage information, storage instructions, and a 120-tablet count. It features the NDC number 0378-5617-78, a barcode, and manufacturer details indicating production in India. The label advises dispensing with a medication guide and emphasizes child-resistant packaging.*

FDA Label Image

Export 02

Levetiracetam 500 mg film-coated tablets label from Mylan Pharmaceuticals Inc. The label shows NDC 0378-5615-78, with directions for dispensing and storage at 20° to 25°C. The package contains 120 tablets and includes barcode and lot, expiry, serial, and GTIN number fields.*

FDA Label Image

Export 03

Levetiracetam 250 mg film-coated tablets, USP, oral dosage form by Mylan Pharmaceuticals Inc. The label shows a panel with red and black text on white background, featuring product name, strength 250 mg, and a photo of one round tablet marked 'LT1'. The package contains 120 tablets and is labeled Rx only. Storage instructions and manufacturer details are provided, along with barcodes and a note for pharmacist to dispense the Medication Guide. The label includes a designated varnish-free area for coding.*

FDA Label Image

Figure 4: Responder Rate (≥ 50% Reduction From Baseline) In Study 4 (Image 05)

Chemical structure of levetiracetam, showing a pyrrolidone ring with an ethyl group, an amide group, and a chiral center indicated by wedge bonds.*

FDA Label Image

Figure 5: Responder Rate For All Patients Ages 1 Month To < 4 Years (≥ 50% Reduction From Baseline) In Study 5 (Image 06)

A formula displayed in text for calculating total daily dose of medication based on patient's weight and daily dose in mg/kg/day divided by concentration, expressed as 100 mg/mL. This instructional text relates to dosing calculations for a drug solution.*

FDA Label Image

Figure 6: Responder Rate (≥ 50% Reduction From Baseline) In Pgtc Seizure Frequency Per Week In Study 7 (Image 07)

Mathematical formula showing the calculation for creatinine clearance (CLcr) based on age, weight, and serum creatinine levels, including an adjustment factor for female patients.*

FDA Label Image

Levetiracetam Tablets, Usp 250 mg Bottle Label (Image 08)

An instructional equation diagram illustrating the calculation of creatinine clearance normalized to a standard body surface area of 1.73 m². The formula shows creatinine clearance (CLcr) in mL/min/1.73 m² as the product of measured creatinine clearance (CLcr in mL/min) divided by the patient's body surface area (BSA in m²), multiplied by 1.73.*

FDA Label Image

Levetiracetam Tablets, Usp 500 mg Bottle Label (Image 09)

Bar graph showing the percentage of patients responding to placebo and Levetiracetam tablets at 1000 mg/day and 3000 mg/day doses. The graph indicates a higher percentage of patient response for both Levetiracetam doses compared to placebo, with values approximately 7.4%, 37.1%, and 39.6%, respectively, and notes statistical significance versus placebo.*

FDA Label Image

Levetiracetam Tablets, Usp 750 mg Bottle Label (Image 10)

A bar graph showing the percentage of patients responding to Levetiracetam tablets at 1000 mg/day and 2000 mg/day doses compared to placebo. The y-axis represents the percentage of patients from 0% to 45%. The graph indicates 6.3% response for placebo, 20.8% for 1000 mg/day, and 35.2% for 2000 mg/day, with a note that these results are statistically significant versus placebo.*

FDA Label Image

Levetiracetam Tablets, Usp 1000 mg Bottle Label (Image 11)

Bar chart comparing the percentage of patients between placebo and Levetiracetam 3000 mg/day tablet treatment groups. The placebo group shows 14.4% of patients, while the Levetiracetam group shows 39.4% of patients, with a note indicating statistical significance versus placebo.*

FDA Label Image

Image 12

A bar chart comparing the percentage of patients responding to Levetiracetam tablets versus placebo. The vertical axis shows the percentage of patients, with Levetiracetam tablets at 44.6% and placebo at 19.6%, indicating a statistically significant result versus placebo.*

FDA Label Image

Image 13

Bar graph comparing the percentage of patients between placebo and Levetiracetam Tablets groups, showing higher patient percentage for Levetiracetam Tablets (43.1%) versus placebo (19.6%), with a note indicating statistical significance versus placebo.*

FDA Label Image

Image 14

A bar chart comparing the percentage of patients between two groups: Placebo (N=84) with 45.2% and Levetiracetam Tablets (N=79) with 72.2%. The chart indicates a statistically significant difference between Levetiracetam Tablets and placebo, marked by an asterisk.*

* 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.