{"effective_time":"20260808","id":"3c52c76c-d0ca-46e7-bd3c-6192b20c995d","openfda":{"application_number":["ANDA074823"],"brand_name":["TERAZOSIN HYDROCHLORIDE"],"generic_name":["TERAZOSIN HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Apnar Pharma LP"],"package_ndc":["24689-001-01","24689-001-10","24689-002-01","24689-002-10","24689-003-01","24689-003-10","24689-004-01","24689-004-10"],"product_ndc":["24689-001","24689-002","24689-003","24689-004"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["260376","313215","313217","313219"],"spl_id":["3c52c76c-d0ca-46e7-bd3c-6192b20c995d"],"spl_set_id":["619dd5cb-46fb-4ad9-a05f-f064261a636b"],"substance_name":["TERAZOSIN HYDROCHLORIDE"],"unii":["D32S14F082"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 24689-001-01 Rx only Terazosin Capsules, USP 1 mg Pharmacist: Please dispense with patient information sheet. 100 capsules NDC 24689-002-01 Rx only Terazosin Capsules, USP 2 mg Pharmacist: Please dispense with patient information sheet. 100 capsules NDC 24689-003-01 Rx only Terazosin Capsules, USP 5 mg Pharmacist: Please dispense with patient information sheet. 100 capsules NDC 24689-004-01 Rx only Terazosin Capsules, USP 10 mg Pharmacist: Please dispense with patient information sheet. 100 capsules 1 mg-100s 2 mg - 100s 5 mg - 100s 10 mg - 100s"],"set_id":"619dd5cb-46fb-4ad9-a05f-f064261a636b","spl_product_data_elements":["TERAZOSIN HYDROCHLORIDE terazosin hydrochloride TERAZOSIN HYDROCHLORIDE TERAZOSIN CROSPOVIDONE, UNSPECIFIED D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE PROPYLENE GLYCOL SHELLAC TITANIUM DIOXIDE AP781 TERAZOSIN HYDROCHLORIDE terazosin hydrochloride TERAZOSIN HYDROCHLORIDE TERAZOSIN CROSPOVIDONE, UNSPECIFIED D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE PROPYLENE GLYCOL SHELLAC TITANIUM DIOXIDE AP782 TERAZOSIN HYDROCHLORIDE terazosin hydrochloride TERAZOSIN HYDROCHLORIDE TERAZOSIN CROSPOVIDONE, UNSPECIFIED D&C RED NO. 28 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE PROPYLENE GLYCOL SHELLAC TITANIUM DIOXIDE AP783 TERAZOSIN HYDROCHLORIDE terazosin hydrochloride TERAZOSIN HYDROCHLORIDE TERAZOSIN CROSPOVIDONE, UNSPECIFIED D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE PROPYLENE GLYCOL SHELLAC TITANIUM DIOXIDE Aqua AP784"],"spl_unclassified_section":["SPL UNCLASSIFIED Terazosin Hydrochloride Capsule, USP"],"version":"1"}