{"effective_time":"20241128","id":"7452a5f1-8acc-4d3b-a69f-c9b73d97f09b","openfda":{"application_number":["ANDA206296"],"brand_name":["esomeprazole magnesium"],"generic_name":["ESOMEPRAZOLE MAGNESIUM"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"package_ndc":["70771-1493-3","70771-1493-9","70771-1493-0","70771-1494-3","70771-1494-9","70771-1494-0"],"product_ndc":["70771-1493","70771-1494"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["606726","606730"],"spl_id":["7452a5f1-8acc-4d3b-a69f-c9b73d97f09b"],"spl_set_id":["6f314f5d-453c-4876-b9b8-20663008dfb1"],"substance_name":["ESOMEPRAZOLE MAGNESIUM DIHYDRATE"],"unii":["36H71644EQ"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1493-3 Esomeprazole Magnesium Delayed-release Capsules, USP 20 mg 30 Capsules NDC 70771-1494-3 Esomeprazole Magnesium Delayed-release Capsules, USP 40 mg 30 Capsules 20 mg 30s label 40 mg 30s label"],"set_id":"6f314f5d-453c-4876-b9b8-20663008dfb1","spl_medguide":["SPL MEDGUIDE"],"spl_product_data_elements":["esomeprazole magnesium esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE ESOMEPRAZOLE ALCOHOL AMMONIA BUTYL ALCOHOL FD&C BLUE NO. 1 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN GLYCERYL MONO- AND DICAPRYLOCAPRATE HYDROXYPROPYL CELLULOSE (90000 WAMW) ISOPROPYL ALCOHOL MAGNESIUM OXIDE MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID POLYSORBATE 80 POTASSIUM HYDROXIDE POVIDONE K30 PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER DARK BLUE OPAQUE (CAP) WHITE OPAQUE (BODY) CAPSULE 441;20mg esomeprazole magnesium esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE ESOMEPRAZOLE ALCOHOL AMMONIA BUTYL ALCOHOL D&C RED NO. 28 FD&C BLUE NO. 1 FERROSOFERRIC OXIDE GELATIN GLYCERYL MONO- AND DICAPRYLOCAPRATE HYDROXYPROPYL CELLULOSE (90000 WAMW) ISOPROPYL ALCOHOL MAGNESIUM OXIDE MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID POLYSORBATE 80 POTASSIUM HYDROXIDE POVIDONE K30 PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER BLUE OPAQUE (CAP) OPAQUE WHITE (BODY) CAPSULE 442;40mg"],"spl_unclassified_section":[""],"version":"6"}