{"effective_time":"20240816","id":"e34d1910-1076-499e-8f3e-1cb18e2a39eb","openfda":{"application_number":["ANDA077625"],"brand_name":["Zonisamide"],"generic_name":["ZONISAMIDE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000175753","N0000008486","M0020790","N0000000235","N0000185503"],"package_ndc":["70771-1142-1","70771-1142-5","70771-1143-1","70771-1143-5","70771-1144-1","70771-1144-5","70771-1144-0"],"pharm_class_cs":["Sulfonamides [CS]"],"pharm_class_epc":["Anti-epileptic Agent [EPC]"],"pharm_class_moa":["Carbonic Anhydrase Inhibitors [MoA]","P-Glycoprotein Inhibitors [MoA]"],"pharm_class_pe":["Decreased Central Nervous System Disorganized Electrical Activity [PE]"],"product_ndc":["70771-1142","70771-1143","70771-1144"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["314285","403966","403967"],"spl_id":["e34d1910-1076-499e-8f3e-1cb18e2a39eb"],"spl_set_id":["4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f"],"substance_name":["ZONISAMIDE"],"unii":["459384H98V"],"upc":["0372578041014","0372578042011"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1142-1 in bottle of 100 Capsules Zonisamide Capsules, 25 mg R x only 100 Capsules NDC 70771-1143-1 in bottle of 100 Capsules Zonisamide Capsules, 50 mg R x only 100 Capsules NDC 70771-1144-1 in bottle of 100 Capsules Zonisamide Capsules, 100 mg R x only 100 Capsules Zonisamide Capsules, 25 mg Zonisamide Capsules, 50 mg Zonisamide Capsules, 100 mg"],"set_id":"4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f","spl_medguide":["Manufactured by: Cadila Healthcare Ltd. India","SPL MEDGUIDE"],"spl_product_data_elements":["Zonisamide Zonisamide ZONISAMIDE ZONISAMIDE FD&C BLUE NO. 1 FD&C RED NO. 4 GELATIN HYDROGENATED COTTONSEED OIL CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE TITANIUM DIOXIDE PINK WHITE CAPSULE ZA;31;25;mg Zonisamide Zonisamide ZONISAMIDE ZONISAMIDE FD&C BLUE NO. 1 FD&C RED NO. 4 GELATIN HYDROGENATED COTTONSEED OIL CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE TITANIUM DIOXIDE PINK WHITE CAPSULE ZA;32;50;mg Zonisamide Zonisamide ZONISAMIDE ZONISAMIDE FD&C BLUE NO. 1 FD&C RED NO. 4 GELATIN HYDROGENATED COTTONSEED OIL CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE TITANIUM DIOXIDE PINK WHITE CAPSULE ZA;33;100;mg"],"version":"8"}