Dimethyl Fumarate Capsule, Delayed Release
Product Images NDC 16729-417

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Dimethyl Fumarate (NDC 16729-417). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare 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

Principal Display Panel (120 mg Capsules: Box Label)

This is a medication with NDC number 16720-416-04. Each hard gelatin capsule contains 120 mg of dimethyl fumarate. It is recommended to take one capsule by mouth twice a day. The medication should be stored at 15°C to 30°C and protected from light. It is manufactured by Intas Pharmaceuticals Limited in India and distributed by Accord Healthcare, Inc. The medication is only available on prescription. The rest of the text is instructions and manufacturing details.*

FDA Label Image

Principal Display Panel (240 mg Capsules: Box Label)

Each INL118 capsule contains 240mg of dimethyl fumarate, a delayed-release medication. The usual dosage is one capsule by mouth twice a day. It is manufactured by Intas Pharmaceuticals Limited in India, and distributed by Accord Healthcare in original packages. The capsules should be stored at 15°C to 30°C (59°F to 86°F), protected from light, and kept in their original containers. There are 46 capsules in the container.*

FDA Label Image

Figure 1 (Dmf Figure1)

This appears to be a chart or graph showing the percentage of subjects with confirmed progression of disability over time or study (measured in weeks), with baseline data at 12 and 24 weeks, for a placebo group (n=408) and a group taking dimethyl fumarate 240 mg BID (n=405). The note explains that confirmed progression of disability is defined as either a 10-point increase on the EDSS from a baseline EDSS >= 10 confirmed for 12 weeks or a 15-point increase on the EDSS from a baseline EDSS of 0 confirmed for 12 weeks.*

FDA Label Image

Principal Display Panel (Starter Pack: Box Label)

This is a pharmaceutical label of Dimethyl Fumarate Delayed-Release Capsules manufactured by Intas Pharmaceuticals Limited. The package contains 14 capsules of 120 mg each for the first 7 days and 46 capsules of 240 mg each for days 8 to 30. The usual dosage and administration instructions are provided on the back panel. The label also specifies to keep the area blank and varnish free for overcoding lot, EXP, and 2D matrix 88 x 22 mm. The product should be stored at 15°C to 30°C (59°F to 86°F), and the original container needs to be protected from light.*

FDA Label Image

Structural Formula (Dmf Structure)

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