{"effective_time":"20250109","id":"654b77ea-07ad-4747-ac35-5a2eb41f4588","openfda":{"application_number":["ANDA211147"],"brand_name":["Azithromycin"],"generic_name":["AZITHROMYCIN"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"package_ndc":["70771-1422-1","70771-1423-2","70771-1424-2","70771-1425-2"],"product_ndc":["70771-1422","70771-1423","70771-1424","70771-1425"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["141963","308459"],"spl_id":["654b77ea-07ad-4747-ac35-5a2eb41f4588"],"spl_set_id":["0b63649d-558c-4250-90ee-af6e1e5c6d2c"],"substance_name":["AZITHROMYCIN DIHYDRATE"],"unii":["5FD1131I7S"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1422-1 Azithromycin for oral suspension, 300 mg 100 mg/5 mL Rx only NDC 70771-1423-2 Azithromycin for oral suspension, 600 mg 200 mg/5 mL Rx only NDC 70771-1424-2 Azithromycin for oral suspension, 900 mg 200 mg/5 mL Rx only NDC 70771-1425-2 Azithromycin for oral suspension, 1200 mg 200 mg/5 mL Rx only Azithromycin oral suspension Azithromycin oral suspension Azithromycin oral suspension Azithromycin oral suspension"],"set_id":"0b63649d-558c-4250-90ee-af6e1e5c6d2c","spl_product_data_elements":["Azithromycin Azithromycin AZITHROMYCIN DIHYDRATE AZITHROMYCIN ANHYDROUS FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SUCROSE XANTHAN GUM WHITE TO LIGHT PINK CHERRY RIPE BANANA Azithromycin Azithromycin AZITHROMYCIN DIHYDRATE AZITHROMYCIN ANHYDROUS FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SUCROSE XANTHAN GUM WHITE TO LIGHT PINK CHERRY RIPE BANANA Azithromycin Azithromycin AZITHROMYCIN DIHYDRATE AZITHROMYCIN ANHYDROUS FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SUCROSE XANTHAN GUM WHITE TO LIGHT PINK CHERRY RIPE BANANA Azithromycin Azithromycin AZITHROMYCIN DIHYDRATE AZITHROMYCIN ANHYDROUS FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SUCROSE XANTHAN GUM WHITE TO LIGHT PINK CHERRY RIPE BANANA"],"spl_unclassified_section":[""],"version":"5"}