Topiramate Capsule, Extended Release
Product Images NDC 69680-178

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 69680-178). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Vitruvias Therapeutics, 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

Image Description (100mg)

Image Description (100mg)
This text provides information about Topiramate 100mg extended-release capsules manufactured by Xiamen LP Pharmaceutical Co., Ltd. The capsules are to be stored between 68-77°F with excursions permitted to 15-30°C (59-86°F). The product is indicated for once-daily dosing and comes in a bottle containing 30 capsules, available via prescription only. It also includes a reference to a medication guide that should be provided separately to patients. The text lists contact information for Vitruvias Therapeutics and includes details for identification and tracking such as NDC, REV, GTIN, SN, EXP, and LOT numbers.*
FDA Label Image

Image Description (150mg)

Image Description (150mg)
Each capsule contains Topiramate 150 mg with a recommended dosage of administering once daily. The medication should be kept out of reach of children and stored in a controlled environment not exceeding 20-28°C (68-77°F). The extended-release capsules are allowed excursions to 15-30°C (59-86°F). It is important to protect the medication from moisture. This medication is manufactured by Xiamen LP Pharmaceutical Co., Ltd. in China and distributed by Vitruvias Therapeutics in the USA. Each package contains 30 capsules, with a unique GTIN code and LOT number provided for tracking purposes. Pharmacies are advised to dispense the medication with a Medication Guide separately to each patient.*
FDA Label Image

Principal Display Panel (200 mg Capsule Bottle Label)

Principal Display Panel (200 mg Capsule Bottle Label)
This text provides important information about Topiramate Extended-Release Capsules at a dosage of 200mg for once-daily dosing. The storage conditions are recommended at 20-25°C (68-77°F) with excursions permitted to 15-30°C (59-86°F). It mentions the manufacturer Xiamen LP Pharmaceutical Co., Ltd., and distributor Vitruvias Therapeutics VITRUVIAS in Auburn, AL, USA. Additionally, it includes a reference number (REV.: B181-30 1124R0), NDC code (69680-181-30), and various product identification codes. Pharmacists are advised to dispense the medication guide provided separately to each patient.*
FDA Label Image

Principal Display Panel (25 mg Capsule Bottle Label)

Principal Display Panel (25 mg Capsule Bottle Label)
This is a prescription medication containing 25mg of Topiramate in extended-release capsules. The recommended dosage is once daily. The medication should be stored in a child-resistant, tight container at 20-25°C. It is important to keep the medication out of reach of children and to protect it from moisture. The manufacturer is Xiamen LP Pharmaceutical Co., Ltd. in China, and it is distributed by VITRUVIAS in the USA. Each package contains 30 capsules and is for prescription use only. Be sure to dispense the Medication Guide provided separately to each patient.*
FDA Label Image

Principal Display Panel (50 mg Capsule Bottle Label)

Principal Display Panel (50 mg Capsule Bottle Label)
This is information about Topiramate extended-release capsules containing 50 mg, with a recommended once-daily dosage. It should be stored in a child-resistant package between 20-25°C, protecting it from moisture. Manufactured by Xiamen LP Pharmaceutical Co., Ltd. in China and distributed by Vitruvias Therapeutics in the USA. The package includes 30 capsules for prescription use only. Pharmacists are advised to provide the Medication Guide to each patient.*
FDA Label Image

Figure 1 (Figure 1)

Figure 1 (Figure 1)
This is a presentation of cumulative rates for time to first seizure comparing two groups of patients taking different doses of topiramate - one group taking 50 mg/day and the other taking 400 mg/day. The x-axis represents time in days, ranging from 0 to 500, while the y-axis shows the cumulative rates of seizures over time.*
FDA Label Image

Figure 2 (Figure 2)

Figure 2 (Figure 2)
This is a list detailing the reduction in seizure frequency from baseline (%) while using topiramate at a dosage of 200 mg/day, compared to a placebo. The data includes different categories of reduction and the corresponding percentages for each category.*
FDA Label Image

Figure 3 (Figure 3)

Figure 3 (Figure 3)
This data presents the change in average monthly migraine period rate from baseline to the double-blind phase for different doses of topiramate compared to a placebo. Study 11 and Study 12 are referenced in the data. The significance levels mentioned are *n<0.010 and **p<0.001.*
FDA Label Image

Chemical Structure (Topiramate01)

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