{"effective_time":"20260416","id":"81ceed98-7fc6-416f-8787-08cbdd76a856","openfda":{"application_number":["ANDA214594"],"brand_name":["norelgestromin and ethinyl estradiol"],"generic_name":["NORELGESTROMIN AND ETHINYL ESTRADIOL"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["M0447349","N0000175602","N0000175825","N0000000100"],"package_ndc":["70771-1777-1","70771-1777-3"],"pharm_class_cs":["Progesterone Congeners [CS]"],"pharm_class_epc":["Progestin [EPC]","Estrogen [EPC]"],"pharm_class_moa":["Estrogen Receptor Agonists [MoA]"],"product_ndc":["70771-1777"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TRANSDERMAL"],"rxcui":["1534809"],"spl_id":["81ceed98-7fc6-416f-8787-08cbdd76a856"],"spl_set_id":["7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a9"],"substance_name":["NORELGESTROMIN","ETHINYL ESTRADIOL"],"unii":["R0TAY3X631","423D2T571U"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1777-3 Norelgestromin and Ethinyl Estradiol Transdermal System 150/35 mcg per day This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. For Transdermal Use Only Contents: 3 Transdermal Systems Rx only Each 15.75 cm 2 system contains 4.678 mg norelgestromin, USP and 0.53 mg ethinyl estradiol, USP. The inactive components are polyisobutylene/polybutene adhesive, crospovidone, lauryl lactate, non-woven polyester fabric, polyester backing film laminate and polyester release liner. See patient instructions. Apply immediately upon removal from pouch. Each transdermal system is intended to be worn 7 days as prescribed. Package not child-resistant. Keep out of reach of children. Do not store unpouched. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 carton"],"set_id":"7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a9","spl_product_data_elements":["norelgestromin and ethinyl estradiol norelgestromin and ethinyl estradiol NORELGESTROMIN NORELGESTROMIN ETHINYL ESTRADIOL ETHINYL ESTRADIOL CROSPOVIDONE LAURYL LACTATE"],"spl_unclassified_section":[""],"version":"2"}