{"effective_time":"20241128","id":"22968719-7127-4aab-b4c4-4497de16ca23","openfda":{"application_number":["ANDA090739"],"brand_name":["Duloxetine"],"generic_name":["DULOXETINE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"package_ndc":["65841-799-06","65841-799-14","65841-799-16","65841-800-06","65841-800-16","65841-800-10","65841-801-06","65841-801-16","65841-801-10"],"product_ndc":["65841-799","65841-800","65841-801"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["596926","596930","596934"],"spl_id":["22968719-7127-4aab-b4c4-4497de16ca23"],"spl_set_id":["f36b414e-ace4-4f04-a80f-75bb25db430d"],"substance_name":["DULOXETINE HYDROCHLORIDE"],"unii":["9044SC542W"],"upc":["0365841800166","0365841801163","0365841799163"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-799-16 Duloxetine Delayed-release Capsules, 20mg 90 Capsules Rx only NDC 65841-800-16 Duloxetine Delayed-release Capsules, 30mg 90 Capsules Rx only NDC 65841-801-16 Duloxetine Delayed-release Capsules, 60mg 90 Capsules Rx only Duloxetine delayed-release capsules Duloxetine delayed-release capsules Duloxetine delayed-release capsules"],"set_id":"f36b414e-ace4-4f04-a80f-75bb25db430d","spl_medguide":["Manufactured by: Cadila Healthcare Ltd. India"],"spl_product_data_elements":["Duloxetine Duloxetine DULOXETINE HYDROCHLORIDE DULOXETINE ALCOHOL AMMONIA BUTYL ALCOHOL D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C YELLOW NO. 6 FERRIC OXIDE YELLOW GELATIN HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) HYPROMELLOSES ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE GREEN WHITE CAPSULE 241;20;mg Duloxetine Duloxetine DULOXETINE HYDROCHLORIDE DULOXETINE FD&C BLUE NO. 1 GELATIN HYPROMELLOSES HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE D&C YELLOW NO. 10 FD&C RED NO. 40 FD&C YELLOW NO. 6 BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC AMMONIA FERRIC OXIDE YELLOW STARCH, CORN BLUE GREEN CAPSULE 242;30;mg Duloxetine Duloxetine DULOXETINE HYDROCHLORIDE DULOXETINE FD&C BLUE NO. 1 GELATIN HYPROMELLOSES HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE FD&C RED NO. 40 BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC AMMONIA FERRIC OXIDE YELLOW STARCH, CORN BLUE WHITE CAPSULE 243;60;mg"],"version":"7"}