{"effective_time":"20230702","id":"d6b98cf3-2e20-47c1-bb31-e8dd31f67cdf","openfda":{"application_number":["ANDA205798"],"brand_name":["Mirtazapine"],"generic_name":["MIRTAZAPINE"],"is_original_packager":[true],"manufacturer_name":["SQUARE PHARMACEUTICALS LIMITED"],"package_ndc":["76483-110-00","76483-111-00","76483-112-00"],"product_ndc":["76483-110","76483-111","76483-112"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["283406","283407","283485"],"spl_id":["d6b98cf3-2e20-47c1-bb31-e8dd31f67cdf"],"spl_set_id":["83093852-d212-408e-98fd-33f4603a9d65"],"substance_name":["MIRTAZAPINE"],"unii":["A051Q2099Q"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 76483-110-00 in unit-dose blister cartons of 30 (5 x 6 blisters) Unit-of-use Tablets Mirtazapine Orally Disintegrating Tablets USP, 15 mg Rx only 30 Tablets NDC 76483-111-00 in unit-dose blister cartons of 30 (5 x 6 blisters) Unit-of-use Tablets Mirtazapine Orally Disintegrating Tablets USP, 30 mg Rx only 30 Tablets NDC 76483-112-00 in unit-dose blister cartons of 30 (5 x 6 blisters) Unit-of-use Tablets Mirtazapine Orally Disintegrating Tablets USP, 45 mg Rx only 30 Tablets Mirtazapine Orally Disintegrating Tablets USP, 15 mg Mirtazapine Orally Disintegrating Tablets USP, 30 mg Mirtazapine Orally Disintegrating Tablets USP, 45 mg"],"set_id":"83093852-d212-408e-98fd-33f4603a9d65","spl_product_data_elements":["Mirtazapine Mirtazapine MIRTAZAPINE MIRTAZAPINE MANNITOL MICROCRYSTALLINE CELLULOSE CROSPOVIDONE POVIDONE K30 ASPARTAME ALPHA-TOCOPHEROL MALTODEXTRIN SILICON DIOXIDE ANHYDROUS CITRIC ACID MAGNESIUM STEARATE SODIUM STEARYL FUMARATE white to off-white 677 Mirtazapine Mirtazapine MIRTAZAPINE MIRTAZAPINE MANNITOL MICROCRYSTALLINE CELLULOSE CROSPOVIDONE POVIDONE K30 ASPARTAME ALPHA-TOCOPHEROL MALTODEXTRIN SILICON DIOXIDE ANHYDROUS CITRIC ACID MAGNESIUM STEARATE SODIUM STEARYL FUMARATE white to off-white 676 Mirtazapine Mirtazapine MIRTAZAPINE MIRTAZAPINE MANNITOL MICROCRYSTALLINE CELLULOSE CROSPOVIDONE POVIDONE K30 ASPARTAME ALPHA-TOCOPHEROL MALTODEXTRIN SILICON DIOXIDE ANHYDROUS CITRIC ACID MAGNESIUM STEARATE SODIUM STEARYL FUMARATE white to off-white 679"],"spl_unclassified_section":[""],"version":"3"}