Levetiracetam Injection
Product Images NDC 0143-9673

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Levetiracetam (NDC 0143-9673). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals 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

Structural Formula (Levetiracetam Injection 1)

Chemical structure of Levetiracetam, showing its molecular arrangement with a pyrrolidone ring attached to an ethyl side chain and an amide group.*

FDA Label Image

Ndc 0143-9673-25 Levetiracetam Injection 500 mg/5 mL (100 mg/ml) Rx Only Must Be Diluted Prior To Administration For Iv Use Only 25 X 5 mL Single Dose Vials Each 5 mL Vial Contains 500 mg Levetiracetam, 8.2 mg Sodium Acetate Trihydrate, 45 mg Sodium Chloride, Glacial Acetic Acid For Ph Adjustment To 6. Usual Dosage: See Package Insert. Discard Unused Portion. Retain In Carton Until Time Of Use. Store At 25ºc (77ºf); Excursions Permitted To 15ºc To 30ºc (59º To 86ºf) [see Usp Controlled Room Temperature]. (Levetiracetam Injection 10)

The image shows a label with printed information including a GTIN, serial number, expiration date, and lot number. It also features a QR code on the left side. There is no visible proprietary or generic product name, strength, or dosage form shown in the image.*

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Figure 1: Responder Rate (≥50% Reduction From Baseline) In Study 1 (Levetiracetam Injection 2)

A bar chart showing the percentage of patients for three groups: Placebo (7.4% of patients), Levetiracetam 1000 mg/day (37.1%), and Levetiracetam 3000 mg/day (39.6%). The chart compares patient response rates by treatment groups.*

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Figure 2: Responder Rate (≥50% Reduction From Baseline) In Study 2: Period A (Levetiracetam Injection 3)

A bar chart showing the percentage of patients across three groups: Placebo (6.3%, N=111), Levetiracetam 1000 mg/day (20.8%, N=106), and Levetiracetam 2000 mg/day (35.2%, N=105). Percentages are displayed above each bar on the y-axis labeled as percentage of patients.*

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Figure 3: Responder Rate (≥50% Reduction From Baseline) In Study 3 (Levetiracetam Injection 4)

A bar chart comparing the percentage of patients for placebo and Levetiracetam 3000 mg/day groups. The placebo group (N=104) shows about 14.4% of patients, while the Levetiracetam group (N=180) shows about 39.4%. The vertical axis represents percent of patients from 0% to 45%, and the horizontal axis labels the two groups.*

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Figure 4: Responder Rate (≥ 50% Reduction From Baseline) In Study 4 (Levetiracetam Injection 5)

A bar chart comparing the percentage of patients in two groups: Placebo (N=97) at 19.6% and Levetiracetam (N=101) at 44.6%. The Y-axis represents the percentage of patients, with values ranging from 0% to 45%.*

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Figure 5: Responder Rate For All Patients Ages 1 Month To < 4 Years (≥ 50% Reduction From Baseline) In Study 5 (Levetiracetam Injection 6)

A bar chart comparing the percentage of patients between two groups: Placebo (N=51) and Levetiracetam (N=58). The graph shows approximately 19.6% of patients in the placebo group and 43.1% in the Levetiracetam group, indicating a difference in patient response or outcome between the groups.*

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

A bar chart depicting percentage values of two groups of patients. The first bar shows 45.2%, and the second bar shows 72.2%, with an asterisk above it indicating statistical significance or emphasis. The y-axis represents the percentage of patients, ranging from 0% to 100%.*

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Ndc 0143-9673-01 Levetiracetam Injection 500 mg/5 mL (100 mg/ml) Must Be Diluted Prior To Administration For Iv Use Only Rx Only 5 mL Single Dose Vial Usual Dosage: See Package Insert. Discard Unused Portion. Retain In Carton Until Time Of Use. Store At 25ºc (77ºf); Excursions Permitted To 15º To 30ºc (59º To 86ºf) [see Usp Controlled Room Temperature]. (Levetiracetam Injection 8)

Levetiracetam Injection 100 mg/mL (500 mg per 5 mL) in a single-dose vial for intravenous use. The label states the solution must be diluted prior to administration and provides storage instructions at 25°C with allowed excursions. Manufactured by Hikma Farmaceutica (Portugal) and distributed by Hikma Pharmaceuticals USA Inc.*

FDA Label Image

Ndc 0143-9673-10 Levetiracetam Injection 500 mg/5 mL (100 mg/ml) Rx Only Must Be Diluted Prior To Administration For Iv Use Only 10 X 5 mL Single Dose Vials Each 5 mL Vial Contains 500 mg Levetiracetam, 8.2 mg Sodium Acetate Trihydrate, 45 mg Sodium Chloride, Glacial Acetic Acid For Ph Adjustment To 6. Usual Dosage: See Package Insert. Discard Unused Portion. Retain In Carton Until Time Of Use. Store At 25ºc (77ºf); Excursions Permitted To 15ºc To 30ºc (59º To 86ºf) [see Usp Controlled Room Temperature]. (Levetiracetam Injection 9)

Levetiracetam Injection 100 mg/mL (500 mg per 5 mL) vial label by Hikma Pharmaceuticals USA Inc. The label indicates 25 single-dose vials of 5 mL each, with instructions that the product must be diluted before intravenous administration. Storage conditions and manufacturer information from Hikma Farmacêutica (Portugal) are also visible.*

* 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.