Topiramate Tablet
Product Images NDC 71610-492

8 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 71610-492). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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

Bottle Label 25 mg (71610 0485 30)

Bottle Label 25 mg (71610 0485 30)
Topiramate 25 mg oral tablets label showing the drug name, strength, and dosage form. The label includes storage instructions specifying 20-25 degrees Celsius (68-77 degrees Fahrenheit) and to keep out of reach of children. It indicates the medication is prescription-only, with a package count of 30 tablets. The manufacturer is listed as Ivagen Pharmaceuticals Inc., and the labeler is Aphena Pharma Solutions - Tennessee, LLC located in Cookeville, TN.*
FDA Label Image

Bottle Label 50 mg (71610 0486 30)

Bottle Label 50 mg (71610 0486 30)
Label for Topiramate USP oral tablets, 50 mg strength, containing 30 tablets. The product is manufactured by Invagen Pharmaceuticals Inc. and repackaged by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. The label includes storage instructions, barcodes, lot number, and expiration date information.*
FDA Label Image

Bottle Label 100 mg (71610 0492 30)

Bottle Label 100 mg (71610 0492 30)
Topiramate USP 100 mg oral tablets label for a bottle containing 30 tablets. The label includes storage instructions to keep the tablets between 20-25 degrees Celsius and states dispensing in a tight, light-resistant container. Manufactured by Imvagen Pharmaceuticals Inc. and labeled by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN 38501. The label also has a barcode, lot number, and expiration date.*
FDA Label Image

Bottle Label 200 mg (71610 0493 15)

Bottle Label 200 mg (71610 0493 15)
Topiramate 200 mg oral tablet label for a 15 tablet bottle from Aphena Pharma Solutions - Tennessee, LLC. The label includes storage instructions to keep the drug between 20-25°C and to dispense in a tight light-resistant container. Manufactured by Invagen Pharmaceuticals Inc., Hauppauge, NY. The label states prescription use only and includes barcodes and lot/expiration information.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Figure 1: Kaplan-meier Estimates Of Cumulative Rates For Time To First Seizure (Topiramate Fig1)

Figure 1: Kaplan-meier Estimates Of Cumulative Rates For Time To First Seizure (Topiramate Fig1)
A Kaplan-Meier curve graph illustrating cumulative rates for time to first seizure over 500 days for two Topiramate dosage groups: 50 mg/day and 400 mg/day. The y-axis represents cumulative seizure rates, and the x-axis shows time in days. The graph compares results between 234 patients on 50 mg/day and 236 on 400 mg/day, showing a significant difference with p = 0.0002.*
FDA Label Image

Table 12: Efficacy Results In Double-blind, Placebo-controlled, Add-on Epilepsy Trials (Topiramate Fig2)

Table 12: Efficacy Results In Double-blind, Placebo-controlled, Add-on Epilepsy Trials (Topiramate Fig2)
A bar graph comparing the change from baseline to double-blind phase in average monthly migraine period rates with doses of Topiramate 50 mg/day, 100 mg/day, and 200 mg/day versus placebo. Data are shown for two studies, Study 10 and Study 11, with error bars representing standard error. Statistically significant reductions are indicated for the 100 mg/day and 200 mg/day doses.*
FDA Label Image

Chemical Structure (Topiramate Str)

Chemical Structure (Topiramate Str)
Chemical structure of topiramate, illustrating its molecular arrangement with various functional groups including sulfonamide, ether, and methyl groups.*

* 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.