{"effective_time":"20241204","id":"800e2d40-d3af-43a0-9ea0-41e2d1d0e8b5","openfda":{"application_number":["ANDA040596"],"brand_name":["Promethazine Hydrochloride"],"generic_name":["PROMETHAZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"package_ndc":["65841-040-01","65841-040-05","65841-040-10","65841-041-01","65841-041-05","65841-041-10","65841-042-01","65841-042-05","65841-042-10"],"product_ndc":["65841-040","65841-041","65841-042"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["992438","992447","992475"],"spl_id":["800e2d40-d3af-43a0-9ea0-41e2d1d0e8b5"],"spl_set_id":["4eaa8291-9cde-4205-857b-925ea8d618ba"],"substance_name":["PROMETHAZINE HYDROCHLORIDE"],"unii":["R61ZEH7I1I"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-040-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 12.5 mg R x only 100 tablets NDC 65841-041-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 25 mg R x only 100 tablets NDC 65841-042-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 50 mg R x only 100 tablets Promethzine Tablets, 12.5 mg Promethazine Tablets, 25 mg Promethazine Tablets, 50 mg"],"set_id":"4eaa8291-9cde-4205-857b-925ea8d618ba","spl_product_data_elements":["Promethazine Hydrochloride Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE PROMETHAZINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED WHITE TO OFF-WHITE ROUND ZC;01 Promethazine Hydrochloride Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE PROMETHAZINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED WHITE TO OFF-WHITE ROUND Z;C;0;2 Promethazine Hydrochloride Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE PROMETHAZINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED WHITE TO OFF-WHITE ROUND ZC03"],"spl_unclassified_section":[""],"version":"7"}