Dimethyl Fumarate Capsule, Delayed Release
FDA Label NDC 70771-1530

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Dimethyl Fumarate (NDC 70771-1530). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

NDC 70771-1532-3

30-Day Starter Pack Carton Label

Dimethyl Fumarate Delayed-release Capsules

120 mg Starter Dose: 14 Capsules

240 mg Regular Dose: 46 Capsules

Rx only

Label (F97ea60b 3e1d 4040 9d97 D9df73851434 03)

Label (F97ea60b 3e1d 4040 9d97 D9df73851434 03)

NDC 70771-1530-7

Dimethyl Fumarate Delayed-release Capsules, 120 mg

14 Capsules

Rx only

Label (F97ea60b 3e1d 4040 9d97 D9df73851434 04)

Label (F97ea60b 3e1d 4040 9d97 D9df73851434 04)

NDC 70771-1531-6

Dimethyl Fumarate Delayed-release Capsules, 240 mg

60 Capsules

Rx only

Label (F97ea60b 3e1d 4040 9d97 D9df73851434 05)

Label (F97ea60b 3e1d 4040 9d97 D9df73851434 05)

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