{"effective_time":"20241203","id":"691b64ae-e6ff-4a10-9973-886901529db0","openfda":{"application_number":["ANDA091352"],"brand_name":["Omeprazole"],"generic_name":["OMEPRAZOLE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000175525","N0000000147","N0000182140"],"package_ndc":["65841-759-06","65841-759-16","65841-759-01","65841-759-05","65841-759-10","65841-760-06","65841-760-16","65841-760-01","65841-760-05","65841-760-10","65841-761-06","65841-761-16","65841-761-01","65841-761-05","65841-761-10"],"pharm_class_epc":["Proton Pump Inhibitor [EPC]"],"pharm_class_moa":["Proton Pump Inhibitors [MoA]","Cytochrome P450 2C19 Inhibitors [MoA]"],"product_ndc":["65841-759","65841-760","65841-761"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["198051","199119","200329"],"spl_id":["691b64ae-e6ff-4a10-9973-886901529db0"],"spl_set_id":["2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2"],"substance_name":["OMEPRAZOLE"],"unii":["KG60484QX9"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-759-01 in bottle of 100 Capsules Omeprazole Delayed-release Capsules USP, 10 mg R x only 100 Capsules NDC 65841-760-01 in bottle of 100 Capsules Omeprazole Delayed-release Capsules USP, 20 mg R x only 100 Capsules NDC 65841-761-01 in bottle of 100 Capsules Omeprazole Delayed-release Capsules USP, 40 mg R x only 100 Capsules Omeprazole DR Capsules, 10 mg Omeprazole DR Capsules, 20 mg Omeprazole DR Capsules, 40 mg"],"set_id":"2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2","spl_medguide":["","SPL MEDGUIDE"],"spl_product_data_elements":["Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE ACETONE FD&C BLUE NO. 1 FD&C GREEN NO. 3 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE AMETHYST PURPLE WHITE CAPSULE ZA;09;10mg Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE ACETONE FD&C BLUE NO. 1 FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE TAN WHITE CAPSULE ZA;10;20mg Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE ACETONE FD&C BLUE NO. 1 FD&C GREEN NO. 3 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE AMETHYST PURPLE WHITE CAPSULE ZA;11;40mg"],"version":"11"}