Dimethyl Fumarate Capsule, Delayed Release
Product Images NDC 51407-441

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Dimethyl Fumarate (NDC 51407-441). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Golden State Medical Supply, 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

51407 441 60

This is a medication in the form of delayed-release capsules containing 240mg of dimethyl fumarate. Each capsule should be taken orally twice a day, and should be swallowed whole and protected from light. The medication contains color additives and must be stored in the original container away from children. The pharmacist should dispense patient information to each patient, and the medication should be stored at controlled room temperature. The medication is manufactured by TWi Pharmaceuticals, Inc. and marketed by GSMS, Incorporated in Camarillo, CA. More patient information can be found on https://gsms.us/.*

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51407 442 14

This is a medication containing 120mg of dimethyl fumarate, packaged in delayed-release capsules. The recommended dosage is one capsule taken orally twice a day, swallowed whole and protected from light. It contains color additives like FD&C Yellow No. 5 (tartrazine) and should be kept out of reach of children. It should be stored at room temperature between 20°C - 25°C (68°F - 77°F) and in the original container. The NDC number is 51407-442-14. The patient should be given additional information by the pharmacist, which can be printed from the website https://gsms.us/. Manufactured by TWi Pharmaceuticals, Inc. and marketed by GSMS, Incorporated.*

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Chemical Structure

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Image Description (Dtfclinical)

This is a chart showing the percentage of subjects with confirmed progression of disability over time in a study comparing release capsules 240mg BID (taken twice a day) to a placebo. The study lasted for 96 weeks and involved 409 participants taking the release capsules and 408 taking the placebo. Confirmed progression of disability is defined as at least a 1.0 point increase on the EDSS from a baseline EDSS of >=1.0 for 12 weeks or at least a 1.5 point increase on the EDSS from a baseline EDSS of 0 confirmed for 12 weeks.*

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