Levetiracetam Tablet, Film Coated, Extended Release
Product Images NDC 43547-346

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Levetiracetam (NDC 43547-346). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Solco Healthcare U.s., 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

Clcr2 (13)

Clcr2 (13)
This text is a medical formula for estimating the creatinine clearance of a patient, which is a measure of kidney function. It involves calculating 140 minus the patient's age in years, then multiplying that number by the patient's weight in kilograms. For female patients, the product is further multiplied by 0.85. Finally, the result is multiplied by the percentage of serum creatinine in the patient's blood, which is expressed in milligrams per deciliter (mg/dL).*
FDA Label Image

Clcr2 (2)

Clcr2 (2)
The given text describes a formula to adjust the CLer (a measurement of renal clearance) based on the body surface area (BSA) of the subject. The formula includes multiplying the CLer value in mL/min/1.73m² with the subject's BSA in m².*
FDA Label Image

Levetiracetam Extended-release Structure (3)

FDA Label Image

Figure 1 (4)

Figure 1 (4)
This appears to be a table showing percentages of something alongside dosages and their corresponding statistical significance. The categories include Placebo, Immediate-release, and Levetiracetam tablets at 1000mg/day and 3000mg/day. However, without additional context or clear labeling it is difficult to determine the exact subject of the percentages and dosages shown.*
FDA Label Image

Figure 2 (5)

Figure 2 (5)
This is a graph showing the percentage of patients taking a placebo, immediate-release levetiracetam tablets 1000 mg/day, and immediate-release levetiracetam tablets 2000 mg/day. The percentages are 35.2% for placebo, 20.8% for 1000 mg/day, and 16.3% for 2000 mg/day. The asterisk indicates that the results for the tablets were statistically significant versus placebo.*
FDA Label Image

Figure 3 (6)

FDA Label Image

Figure 4 (7)

Figure 4 (7)
This is a graph showing the results of a clinical trial comparing the effectiveness of Immediate-release levetiracetam tablets versus a Placebo. The graph displays two bars, one for each group. The percentage of participants who benefited from the treatment is indicated on the y-axis. The group that received the treatment showed a statistically significant improvement compared to the placebo group.*
FDA Label Image

Image 01

Image 01
This is a description of the medication Levetiracetam Extended-Release Tablets, USP. Each tablet contains 500 mg of the active ingredient, and the usual dosage is resistant to closure by children. The tablets should be stored in a tight, light-resistant container at a temperature between 2°C-25°C (68°F-77°F) with permitted excursions between 15°C-30°C (59°F-86°F), as indicated by the USP. The medication is manufactured by Zhejiang Huzhai Pharmaceutical Co., Ltd in China and distributed by Solco Healthcare US, LLC in Somerset, NJ. The package insert includes complete dosage recommendations and indicates that the medication is taken once daily. The text also includes guidelines for manufacturing the tablets and indicates an FPO area that should be left uncoated.*
FDA Label Image

Image 02

Image 02
Each film-coated tablet contains 750 mg of levetiracetam, USP. The usual dosage is mentioned in the package insert with immediate dosage recommendations and once-daily dosing. It is recommended to store the extended-release tablets between 15°C and 30°C (59°F and 86°F) in a controlled room temperature according to USP guidelines. These tablets are manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd., located in Xungiao, Linhai, Zhejiang 317024, China, and distributed by Solco Healthcare US, LLC, based in Somerset, NJ 08873, USA. The description also includes a revision date of 20164301 and mentions that the box is FPO to indicate the uncoated area.*
FDA Label Image

Image 03

Image 03
This is a description of Levetiracetam Extended-Release tablets, USP with a dosage strength of 1.50%. It contains a request for a pharmacist to dispense the medication along with a non-coating area and a total of 60 tablets.*
FDA Label Image

Image 04

Image 04
Each tablet of this medication contains 750 mg of leviracetam USP. The usual dosage instructions can be found in the package insert which also includes recommendations for once-daily dosing. The drug must be stored in a light-resistant container with a child-resistant closure at controlled room temperature. The tablets are manufactured by Prinston Laboratories and distributed by Solco Healthcare. No additional information is available due to the limited text provided.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.