Oxcarbazepine Suspension
Product Images NDC 65162-649

20 FDA label images from Amneal Pharmaceuticals Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Oxcarbazepine (NDC 65162-649). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals 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

9f14a9c2-figure-01 (Oxcarbazepine Oral Suspension Usp 1)

9f14a9c2-figure-01 (Oxcarbazepine Oral Suspension Usp 1)
Chemical structure of oxcarbazepine depicted as a molecular diagram showing the fused ring system with a ketone group and an amide group attached to a nitrogen atom.*
FDA Label Image

9f14a9c2-figure-02 (Oxcarbazepine Oral Suspension Usp 2)

9f14a9c2-figure-02 (Oxcarbazepine Oral Suspension Usp 2)
A Kaplan-Meier survival curve graph showing exit rates over time from Day 2 to Day 11 for treatment groups with Oxcarbazepine and placebo. The y-axis represents the exit rate, while the x-axis represents days on trial starting from Day 2 at 8 am. The graph includes a log-rank test p-value of 0.0001, indicating statistically significant differences between the Oxcarbazepine and placebo groups.*
FDA Label Image

9f14a9c2-figure-03 (Oxcarbazepine Oral Suspension Usp 3)

9f14a9c2-figure-03 (Oxcarbazepine Oral Suspension Usp 3)
A Kaplan-Meier survival curve showing seizure rate over days from the first dose to the first seizure. The solid line represents the Oxcarbazepine treatment group, and the dashed line represents the placebo group. The chart includes a log-rank test p-value of 0.046 indicating statistical comparison between groups.*
FDA Label Image

9f14a9c2-figure-04 (Oxcarbazepine Oral Suspension Usp 4)

9f14a9c2-figure-04 (Oxcarbazepine Oral Suspension Usp 4)
A line graph depicting exit rate over time (days) for two treatment groups labeled HIGH and LOW. The x-axis shows time to exit in days from 0 to 130, and the y-axis shows exit rate from 0.0 to 1.0. The LOW treatment group (dashed line) reaches a higher and faster exit rate compared to the HIGH group (solid line). A log-rank test p-value of 0.0001 is indicated on the graph.*
FDA Label Image

9f14a9c2-figure-05 (Oxcarbazepine Oral Suspension Usp 5)

9f14a9c2-figure-05 (Oxcarbazepine Oral Suspension Usp 5)
A line graph showing exit rate over time (days) for two treatment groups labeled HIGH and LOW, with HIGH represented by a solid line and LOW by a dashed line. The x-axis represents time to exit in days, and the y-axis represents exit rate from 0 to 1.0. The graph includes a log-rank test p-value of 0.0001, indicating statistical comparison of the two groups.*
FDA Label Image

Bottle Adapter (Oxcarbazepine Oral Suspension Usp 6)

Bottle Adapter (Oxcarbazepine Oral Suspension Usp 6)
The image shows a clear depiction of an oral suspension bottle with a white cap and a sealed tamper-evident aluminum foil seal. The bottle is unlabeled and contains no visible text or branding. This corresponds to the Oxcarbazepine 300 mg/5mL oral suspension by Amneal Pharmaceuticals LLC.*
FDA Label Image

Bottle (Oxcarbazepine Oral Suspension Usp 7)

Bottle (Oxcarbazepine Oral Suspension Usp 7)
An instructional line drawing of an oral dosing syringe for liquid medication, labeled with arrows pointing to the 'Barrel' and the 'Plunger'. This diagram illustrates the main components of the syringe used for measuring and administering oral suspension medications.*
FDA Label Image

Syringe (Oxcarbazepine Oral Suspension Usp 8)

Syringe (Oxcarbazepine Oral Suspension Usp 8)
Illustration showing a hand holding a bottle, shaking the suspension medication. The image demonstrates the proper technique for mixing the oral suspension before use.*
FDA Label Image

Step 1 (Oxcarbazepine Oral Suspension Usp 9)

Step 1 (Oxcarbazepine Oral Suspension Usp 9)
Illustration showing how to open a bottle by pressing down and twisting off the cap, with the cap removed and placed to the right of the bottle. The bottle is likely for an oral suspension such as Oxcarbazepine 300 mg/5 mL.*
FDA Label Image

Step 2 (Oxcarbazepine Oral Suspension Usp 10)

Step 2 (Oxcarbazepine Oral Suspension Usp 10)
Instructional illustrations showing proper mixing and dosing technique for oral suspension. The first illustration depicts a hand shaking a bottle to mix the medication. The second illustration shows a syringe being inserted into the bottle's opening for withdrawal of the suspension.*
FDA Label Image

Step 3 (Oxcarbazepine Oral Suspension Usp 11)

Step 3 (Oxcarbazepine Oral Suspension Usp 11)
An instructional diagram showing how to use an oral suspension dropper. The top image illustrates pulling the plunger upward to draw the medication, and the bottom image shows pushing the plunger down to dispense a measured dose, with a close-up of the dose measurement markings.*
FDA Label Image

Step 5 (Oxcarbazepine Oral Suspension Usp 12)

Step 5 (Oxcarbazepine Oral Suspension Usp 12)
An instructional illustration showing a hand using a syringe to draw liquid medicine from an open bottle. The syringe is being rotated or manipulated by the thumb and forefinger, suggesting a step in measuring or preparing the oral suspension medication.*
FDA Label Image

Step 7 (Oxcarbazepine Oral Suspension Usp 13)

Step 7 (Oxcarbazepine Oral Suspension Usp 13)
An instructional illustration showing a child taking oral suspension medication from a dosing syringe, and a separate image demonstrating how to fill a dosing syringe with liquid medication from a cup. The images are intended to guide proper measurement and administration of oral suspension.*
FDA Label Image

Step 9 (Oxcarbazepine Oral Suspension Usp 14)

Step 9 (Oxcarbazepine Oral Suspension Usp 14)
Label for Oxcarbazepine Oral Suspension, USP, 300 mg per 5 mL, distributed by Amneal Pharmaceuticals LLC. The label includes dosage form as suspension for oral use, net contents of 250 mL, storage instructions to keep within 20° to 25°C with allowances between 15° to 30°C, and directions to shake well before use. It also notes use within 7 weeks of opening and mentions the inclusion of a separate Medication Guide for the pharmacist to dispense.*
FDA Label Image

Step 10 (Oxcarbazepine Oral Suspension Usp 15)

Step 10 (Oxcarbazepine Oral Suspension Usp 15)
Packaging label for Oxcarbazepine Oral Suspension, USP 300 mg/5 mL by Amneal Pharmaceuticals LLC. The label indicates a 250 mL bottle, with instructions to shake well before use and storage recommendations. The label includes the NDC 65162-649 and notes the product is for oral use only.*
FDA Label Image

Step 11 (Oxcarbazepine Oral Suspension Usp 16)

Step 11 (Oxcarbazepine Oral Suspension Usp 16)
An instructional diagram showing how to measure and withdraw oral suspension medication using a dosing syringe from a bottle. The image highlights the syringe with volume markings and demonstrates drawing liquid up to a precise dose level.*
FDA Label Image

Step 12 (Oxcarbazepine Oral Suspension Usp 17)

Step 12 (Oxcarbazepine Oral Suspension Usp 17)
An instructional diagram showing a hand using a syringe to withdraw liquid medication from a bottle, indicating the correct technique for drawing oral suspension from the container.*
FDA Label Image

Step 13 (Oxcarbazepine Oral Suspension Usp 18)

Step 13 (Oxcarbazepine Oral Suspension Usp 18)
An instructional illustration showing the use of an oral syringe to measure and administer Oxcarbazepine suspension. On the left, a child is depicted receiving the medication orally from the syringe. On the right, the syringe is shown being filled with the liquid suspension from a container.*
FDA Label Image

Carton (Oxcarbazepine Oral Suspension Usp 19)

Carton (Oxcarbazepine Oral Suspension Usp 19)
Label for Oxcarbazepine Oral Suspension USP 300 mg/5 mL in a 250 mL carton by Amneal Pharmaceuticals LLC. The label includes dosing details, storage instructions, and a note to shake well before use. It features the Amneal logo and states Rx only with barcode and NDC 65162-649-78.*
FDA Label Image

Label (Oxcarbazepine Oral Suspension Usp 20)

Label (Oxcarbazepine Oral Suspension Usp 20)
Label for Oxcarbazepine Oral Suspension USP 300 mg/5 mL by Amneal Pharmaceuticals LLC. The label includes storage instructions, dosage note to see package insert, and directions to shake well before use. It shows the NDC 65162-649-78, net contents of 250 mL, and cautions to use within 7 weeks of opening.*

* 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.