{"effective_time":"20241128","id":"12ad7193-e8e8-49cd-871c-e7a4c47f32c4","openfda":{"application_number":["ANDA091134"],"brand_name":["Etodolac"],"generic_name":["ETODOLAC"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000000160","M0001335","N0000175722"],"package_ndc":["65841-777-14","65841-777-01","65841-777-05","65841-777-10","65841-777-30","65841-777-77","65841-778-14","65841-778-01","65841-778-05","65841-778-10","65841-778-30","65841-778-77","65841-779-14","65841-779-01","65841-779-05","65841-779-10","65841-779-30","65841-779-77"],"pharm_class_cs":["Anti-Inflammatory Agents, Non-Steroidal [CS]"],"pharm_class_epc":["Nonsteroidal Anti-inflammatory Drug [EPC]"],"pharm_class_moa":["Cyclooxygenase Inhibitors [MoA]"],"product_ndc":["65841-777","65841-778","65841-779"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["310245","310247","359500"],"spl_id":["12ad7193-e8e8-49cd-871c-e7a4c47f32c4"],"spl_set_id":["0c5f8631-f013-4bbb-b610-0a8a1311844e"],"substance_name":["ETODOLAC"],"unii":["2M36281008"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-777-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 400 mg R x only 60 tablets NDC 65841-778-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 500 mg R x only 60 tablets NDC 65841-779-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 600 mg R x only 60 tablets Etodolac Extended-release Tablets USP, 400 mg Etodolac Extended-release Tablets USP, 500 mg Etodolac Extended-release Tablets USP, 600 mg"],"set_id":"0c5f8631-f013-4bbb-b610-0a8a1311844e","spl_medguide":["SPL MEDGUIDE"],"spl_product_data_elements":["Etodolac Etodolac ETODOLAC ETODOLAC D&C YELLOW NO. 10 ETHYLCELLULOSE (100 MPA.S) FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE TRIACETIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS ORANGE OVAL 271 Etodolac Etodolac ETODOLAC ETODOLAC ETHYLCELLULOSE (100 MPA.S) FD&C BLUE NO. 2 FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE TRIACETIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS GRAY OVAL 272 Etodolac Etodolac ETODOLAC ETODOLAC ETHYLCELLULOSE (100 MPA.S) FD&C BLUE NO. 2 FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE TRIACETIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS BLUE OVAL 273"],"spl_unclassified_section":[""],"version":"8"}