{"effective_time":"20250401","id":"d8dceb92-b903-4b29-b3e6-4651fbc598fe","openfda":{"application_number":["ANDA210538"],"brand_name":["dimethyl fumarate"],"generic_name":["DIMETHYL FUMARATE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"package_ndc":["70771-1532-3","70771-1530-7","70771-1531-8","70771-1531-6"],"product_ndc":["70771-1530","70771-1532","70771-1531"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["1373483","1373491","1373497"],"spl_id":["d8dceb92-b903-4b29-b3e6-4651fbc598fe"],"spl_set_id":["7203a262-de0f-42dd-b4fb-8856758b82e9"],"substance_name":["DIMETHYL FUMARATE"],"unii":["FO2303MNI2"]},"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 label label label"],"set_id":"7203a262-de0f-42dd-b4fb-8856758b82e9","spl_product_data_elements":["dimethyl fumarate dimethyl fumarate dimethyl fumarate dimethyl fumarate DIMETHYL FUMARATE MONOMETHYL FUMARATE 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 OPAQUE LIGHT GREEN CAP OPAQUE WHITE BODY CAPSULE 1204 dimethyl fumarate dimethyl fumarate DIMETHYL FUMARATE MONOMETHYL FUMARATE 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 OPAQUE LIGHT GREEN CAP OPAQUE LIGHT GREEN BODY CAPSULE 1205 dimethyl fumarate dimethyl fumarate DIMETHYL FUMARATE MONOMETHYL FUMARATE 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 DICAPRYLATE 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 OPAQUE LIGHT GREEN CAP OPAQUE WHITE BODY CAPSULE 1204 dimethyl fumarate dimethyl fumarate DIMETHYL FUMARATE MONOMETHYL FUMARATE 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 DICAPRYLATE 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 OPAQUE LIGHT GREEN CAP OPAQUE LIGHT GREEN BODY CAPSULE 1205"],"spl_unclassified_section":[""],"version":"5"}