{"effective_time":"20230421","id":"93d304a6-249a-4887-9a4a-dfedbd209cc1","openfda":{"application_number":["ANDA202985"],"brand_name":["estradiol"],"generic_name":["ESTRADIOL"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["M0447348","N0000175825","N0000000100"],"package_ndc":["70771-1401-1","70771-1401-4","70771-1402-1","70771-1402-4","70771-1403-1","70771-1403-4","70771-1404-1","70771-1404-4","70771-1405-1","70771-1405-4","70771-1406-1","70771-1406-4"],"pharm_class_cs":["Estradiol Congeners [CS]"],"pharm_class_epc":["Estrogen [EPC]"],"pharm_class_moa":["Estrogen Receptor Agonists [MoA]"],"product_ndc":["70771-1401","70771-1402","70771-1403","70771-1404","70771-1405","70771-1406"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TRANSDERMAL"],"rxcui":["238003","238004","241527","242333","403922","403923"],"spl_id":["93d304a6-249a-4887-9a4a-dfedbd209cc1"],"spl_set_id":["8b672c79-0896-4d6e-b225-299e89068ad7"],"substance_name":["ESTRADIOL"],"unii":["4TI98Z838E"],"upc":["0370771140343","0370771140244","0370771140145","0370771140442","0370771140541","0370771140640"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771- 1401 -4 Estradiol Transdermal System, USP 0.025 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1402 -4 Estradiol Transdermal System, USP 0.0375 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1403 -4 Estradiol Transdermal System, USP 0.05 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1404 -4 Estradiol Transdermal System, USP 0.06 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1405 -4 Estradiol Transdermal System, USP 0.075 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1406 -4 Estradiol Transdermal System, USP 0.1 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA Estradiol Transdermal System USP, 0.025mg per day Estradiol Transdermal System USP, 0.0375mg per day Estradiol Transdermal System USP, 0.05mg per day Estradiol Transdermal System USP, 0.06mg per day Estradiol Transdermal System USP, 0.075mg per day Estradiol Transdermal System USP, 0.1mg per day"],"set_id":"8b672c79-0896-4d6e-b225-299e89068ad7","spl_product_data_elements":["estradiol estradiol ESTRADIOL ESTRADIOL 2-ETHYLHEXYL ACRYLATE 2-HYDROXYETHYL ACRYLATE ETHYL OLEATE GLYCERYL LAURATE GLYCIDYL METHACRYLATE ISOPROPYL MYRISTATE POVIDONE SILICON DIOXIDE VINYL ACETATE estradiol estradiol ESTRADIOL ESTRADIOL 2-ETHYLHEXYL ACRYLATE 2-HYDROXYETHYL ACRYLATE ETHYL OLEATE GLYCERYL LAURATE GLYCIDYL METHACRYLATE ISOPROPYL MYRISTATE POVIDONE SILICON DIOXIDE VINYL ACETATE estradiol estradiol ESTRADIOL ESTRADIOL 2-ETHYLHEXYL ACRYLATE 2-HYDROXYETHYL ACRYLATE ETHYL OLEATE GLYCERYL LAURATE GLYCIDYL METHACRYLATE ISOPROPYL MYRISTATE POVIDONE SILICON DIOXIDE VINYL ACETATE estradiol estradiol ESTRADIOL ESTRADIOL 2-ETHYLHEXYL ACRYLATE 2-HYDROXYETHYL ACRYLATE ETHYL OLEATE GLYCERYL LAURATE GLYCIDYL METHACRYLATE ISOPROPYL MYRISTATE POVIDONE SILICON DIOXIDE VINYL ACETATE estradiol estradiol ESTRADIOL ESTRADIOL 2-ETHYLHEXYL ACRYLATE 2-HYDROXYETHYL ACRYLATE ETHYL OLEATE GLYCERYL LAURATE GLYCIDYL METHACRYLATE ISOPROPYL MYRISTATE POVIDONE SILICON DIOXIDE VINYL ACETATE estradiol estradiol ESTRADIOL ESTRADIOL 2-ETHYLHEXYL ACRYLATE 2-HYDROXYETHYL ACRYLATE ETHYL OLEATE GLYCERYL LAURATE GLYCIDYL METHACRYLATE ISOPROPYL MYRISTATE POVIDONE SILICON DIOXIDE VINYL ACETATE"],"spl_unclassified_section":["SPL UNCLASSIFIED"],"version":"1"}