{"effective_time":"20260214","id":"008fc213-caa0-4d52-9ee2-e3628c19b90b","openfda":{"application_number":["ANDA213981"],"brand_name":["bosentan"],"generic_name":["BOSENTAN"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"package_ndc":["70771-1908-7","70771-1908-8"],"product_ndc":["70771-1908"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["1989081"],"spl_id":["008fc213-caa0-4d52-9ee2-e3628c19b90b"],"spl_set_id":["b88cc559-93ae-42db-9c38-fb5e9c4802e6"],"substance_name":["BOSENTAN"],"unii":["Q326023R30"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1908-8 Bosentan Tablets for Oral Suspension, 32 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. Phenylketonurics: Contains Phenylalanine 2.08 mg per tablet for oral suspension. 56 Tablets (4 x 14 unit-dose) Rx only Zydus image"],"set_id":"b88cc559-93ae-42db-9c38-fb5e9c4802e6","spl_medguide":[""],"spl_product_data_elements":["bosentan bosentan BOSENTAN BOSENTAN ANHYDROUS ACESULFAME POTASSIUM ASPARTAME CROSCARMELLOSE SODIUM DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER MAGNESIUM STEARATE MANNITOL SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN STEARIC ACID TALC off-white to pale yellow 1508"],"spl_unclassified_section":[""],"version":"1"}