{"effective_time":"20241128","id":"b0459347-b3de-466e-b386-85665dd294c9","openfda":{"application_number":["ANDA206409"],"brand_name":["Eletriptan hydrobromide"],"generic_name":["ELETRIPTAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"package_ndc":["70771-1107-3","70771-1107-0","70771-1107-2","70771-1107-4","70771-1107-6","70771-1108-3","70771-1108-5","70771-1108-2","70771-1108-4","70771-1108-6"],"product_ndc":["70771-1107","70771-1108"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["359493","359494"],"spl_id":["b0459347-b3de-466e-b386-85665dd294c9"],"spl_set_id":["481ae7d4-9e57-424a-9d07-2920954b6ddc"],"substance_name":["ELETRIPTAN HYDROBROMIDE"],"unii":["M41W832TA3"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Eletriptan hydrobromide Tablets, 20 mg NDC 70771-1107-3 Rx only 30 Tablets Eletriptan hydrobromide Tablets, 40 mg NDC 70771-1108-3 Rx only 30 Tablets ELETRIPTAN HYDROBROMIDE TABLET Eletriptan hydrobromide tablet"],"set_id":"481ae7d4-9e57-424a-9d07-2920954b6ddc","spl_product_data_elements":["Eletriptan hydrobromide Eletriptan hydrobromide ELETRIPTAN HYDROBROMIDE ELETRIPTAN ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 2--ALUMINUM LAKE FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 112 POVIDONE K30 TITANIUM DIOXIDE TRIACETIN ORANGE TO MOTTLED ORANGE ROUND 922 Eletriptan hydrobromide Eletriptan hydrobromide ELETRIPTAN HYDROBROMIDE ELETRIPTAN ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 112 POVIDONE K30 TITANIUM DIOXIDE TRIACETIN BROWN ROUND 923"],"spl_unclassified_section":[""],"version":"7"}