Levetiracetam Injection
Product Images NDC 0143-9574

10 FDA label images from Hikma Pharmaceuticals Usa Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Levetiracetam (NDC 0143-9574). 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.

Product Images & Figures Index

FDA Label Image

Chemical Structure (Levetiracetam Injection Novaplus 1)

Chemical Structure (Levetiracetam Injection Novaplus 1)
Chemical structure diagram of levetiracetam showing the molecular arrangement of the active ingredient, including a pyrrolidinone ring, ethyl group, and amide functional group.*
FDA Label Image

Ndc 0143-9574-25 Rx Only Levetiracetam Injection For Iv Use Only 500 mg/5 mL (100 mg/ml) Must Be Diluted Prior To Administration 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 15º To 30ºc (59º To 86ºf) [see Usp Controlled Room Temperature]. (Levetiracetam Injection Novaplus 10)

Ndc 0143-9574-25 Rx Only Levetiracetam Injection For Iv Use Only 500 mg/5 mL (100 mg/ml) Must Be Diluted Prior To Administration 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 15º To 30ºc (59º To 86ºf) [see Usp Controlled Room Temperature]. (Levetiracetam Injection Novaplus 10)
Label section for Levetiracetam injection 100 mg/mL by Hikma Pharmaceuticals USA Inc. It includes a QR code, GTIN number, serial number, expiration date placeholder, and lot number placeholder information in a barcode format.*
FDA Label Image

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

Figure 1: Responder Rate (≥50% Reduction From Baseline) In Study 1 (Levetiracetam Injection Novaplus 2)
A bar chart comparing the percentage of patients across three groups: Placebo (7.4%), Levetiracetam 1000 mg/day (37.1%), and Levetiracetam 3000 mg/day (39.6%). The chart displays patient response rates by treatment group.*
FDA Label Image

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

Figure 2: Responder Rate (≥50% Reduction From Baseline) In Study 2: Period A (Levetiracetam Injection Novaplus 3)
A vertical bar chart displaying the percentage of patients across three groups: Placebo (111 patients), Levetiracetam 1000 mg/day (106 patients), and Levetiracetam 2000 mg/day (105 patients). The chart shows increasing percentages of patients from Placebo to higher Levetiracetam dosages, with values approximately 6.3%, 20.8%, and 35.2%, respectively.*
FDA Label Image

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

Figure 3: Responder Rate (≥50% Reduction From Baseline) In Study 3 (Levetiracetam Injection Novaplus 4)
A bar chart comparing the percentage of patients in two groups: placebo (N=104) and Levetiracetam 3000 mg/day (N=180). The chart shows approximately 14.4% of patients in the placebo group and 39.4% in the Levetiracetam group, with an asterisk marking the latter bar.*
FDA Label Image

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

Figure 4: Responder Rate (≥ 50% Reduction From Baseline) In Study 4 (Levetiracetam Injection Novaplus 5)
A bar chart comparing the percentage of patients between two groups: Placebo (N=97) with approximately 19.6% and Levetiracetam (N=101) with approximately 44.6%. The vertical axis is labeled as percentage of patients.*
FDA Label Image

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

Figure 5: Responder Rate For All Patients Ages 1 Month To < 4 Years (≥ 50% Reduction From Baseline) In Study 5 (Levetiracetam Injection Novaplus 6)
Bar graph comparing the percentage of patients between two groups: Placebo (N=51) with 19.6% and Levetiracetam (N=58) with 43.1%. The vertical axis shows the percentage of patients ranging from 0% to 45%, depicting a higher percentage response for the Levetiracetam group versus placebo.*
FDA Label Image

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

Figure 6: Responder Rate (≥50% Reduction From Baseline) In Pgtc Seizure Frequency Per Week In Study 7 (Levetiracetam Injection Novaplus 7)
A bar graph comparing the percentage of patients between two groups: Placebo and Levetiracetam. The y-axis shows the percentage of patients from 0% to 100%. The Placebo group (N=84) has a bar reaching 45.2%, while the Levetiracetam group (N=79) has a bar reaching 72.2% with an asterisk indicating significance.*
FDA Label Image

Ndc 0143-9574-01 Rx Only Levetiracetam Injection For Iv Use Only 500 mg/5 mL (100 mg/ml) Must Be Diluted Prior To Administration 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 Tem- Perature]. (Levetiracetam Injection Novaplus 8)

Ndc 0143-9574-01 Rx Only Levetiracetam Injection For Iv Use Only 500 mg/5 mL (100 mg/ml) Must Be Diluted Prior To Administration 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 Tem- Perature]. (Levetiracetam Injection Novaplus 8)
Levetiracetam Injection 100 mg/mL intravenous solution. The label indicates 500 mg per 5 mL single-dose vial and specifies that the drug must be diluted prior to administration. Manufactured by Hikma Farmacêutica (Portugal), distributed by Hikma Pharmaceuticals USA Inc. Additional storage and usage instructions are provided on the label.*
FDA Label Image

Ndc 0143-9574-10 Rx Only Levetiracetam Injection For Iv Use Only 500 mg/5 mL (100 mg/ml) Must Be Diluted Prior To Administration 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 15º To 30ºc (59º To 86ºf) [see Usp Controlled Room Temperature]. (Levetiracetam Injection Novaplus 9)

Ndc 0143-9574-10 Rx Only Levetiracetam Injection For Iv Use Only 500 mg/5 mL (100 mg/ml) Must Be Diluted Prior To Administration 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 15º To 30ºc (59º To 86ºf) [see Usp Controlled Room Temperature]. (Levetiracetam Injection Novaplus 9)
Levetiracetam Injection 500 mg per 5 mL (100 mg/mL) intravenous injection, supplied as 25 single dose 5 mL vials. The label includes instructions to dilute prior to administration and storage conditions. Manufactured by Hikma Farmacéutica (Portugal) and distributed by Hikma Pharmaceuticals USA Inc.*

* 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.