Dimethyl Fumarate Delayed-release Capsules

SPL v5

SPL

SPL Set ID 7203a262-de0f-42dd-b4fb-8856758b82e9

Route

ORAL

Published

Effective Date 2020-09-23

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Monomethyl Fumarate (120 mg)

Inactive Ingredients

Ammonia Cellulose, Microcrystalline Croscarmellose Sodium D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Gelatin Glyceryl Mono- And Dicaprylocaprate Magnesium Stearate Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Methacrylic Acid And Ethyl Acrylate Copolymer Polysorbate 80 Potassium Hydroxide Povidone K30 Propylene Glycol Shellac Silicon Dioxide Sodium Lauryl Sulfate Talc Titanium Dioxide Triethyl Citrate Glyceryl Mono- And Dicaprylate

Identifiers & Packaging

Pill Appearance

Imprint: 1205 Shape: capsule Color: green Color: white Size: 22 mm Score: 1

Marketing Status

ANDA Completed Since 2020-09-28 Until 2025-04-01

Description

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 NDC 70771-1530-7 Dimethyl Fumarate Delayed-release Capsules, 120 mg 14 Capsules Rx only NDC 70771-1531-6 Dimethyl Fumarate Delayed-release Capsules, 240 mg 60 Capsules Rx only

Medication Information

Description

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

NDC 70771-1530-7

Dimethyl Fumarate Delayed-release Capsules, 120 mg

14 Capsules

Rx only

NDC 70771-1531-6

Dimethyl Fumarate Delayed-release Capsules, 240 mg

60 Capsules

Rx only

Structured Label Content

Package Label.principal Display Panel (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

NDC 70771-1530-7

Dimethyl Fumarate Delayed-release Capsules, 120 mg

14 Capsules

Rx only

NDC 70771-1531-6

Dimethyl Fumarate Delayed-release Capsules, 240 mg

60 Capsules

Rx only

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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 NDC 70771-1530-7 Dimethyl Fumarate Delayed-release Capsules, 120 mg 14 Capsules Rx only NDC 70771-1531-6 Dimethyl Fumarate Delayed-release Capsules, 240 mg 60 Capsules Rx only"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:46:26.305634 · Updated: 2026-03-14T22:24:49.636444