{"effective_time":"20221105","id":"be4934db-c496-4b06-84c6-587cb656d5fc","openfda":{"application_number":["ANDA203000"],"brand_name":["valsartan and hydrochlorothiazide"],"generic_name":["VALSARTAN AND HYDROCHLOROTHIAZIDE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000000070","N0000175561","N0000175359","N0000175419","M0471776"],"package_ndc":["70771-1485-9","70771-1485-0","70771-1485-4","70771-1486-9","70771-1486-0","70771-1486-4","70771-1487-9","70771-1487-0","70771-1487-4","70771-1488-9","70771-1488-0","70771-1488-4","70771-1489-9","70771-1489-0","70771-1489-4"],"pharm_class_cs":["Thiazides [CS]"],"pharm_class_epc":["Angiotensin 2 Receptor Blocker [EPC]","Thiazide Diuretic [EPC]"],"pharm_class_moa":["Angiotensin 2 Receptor Antagonists [MoA]"],"pharm_class_pe":["Increased Diuresis [PE]"],"product_ndc":["70771-1485","70771-1486","70771-1487","70771-1488","70771-1489"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["200284","200285","349353","636042","636045"],"spl_id":["be4934db-c496-4b06-84c6-587cb656d5fc"],"spl_set_id":["bd199010-1d85-4011-939c-4704ecfaba1f"],"substance_name":["VALSARTAN","HYDROCHLOROTHIAZIDE"],"unii":["80M03YXJ7I","0J48LPH2TH"],"upc":["0370771148905"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg NDC 70771-1485-0 in bottle of 1000 tablets 1000 tablets Rx only Valsartan and Hydrochlorothiazide Tablets USP, 160/12.5 mg NDC 70771-1486-0 in bottle of 1000 tablets 1000 tablets Rx only Valsartan and Hydrochlorothiazide Tablets USP, 160/25 mg NDC 70771-1487-0 in bottle of 1000 tablets 1000 tablets Rx only Valsartan and Hydrochlorothiazide Tablets USP, 320/12.5 mg NDC 70771-1488-0 in bottle of 1000 tablets 1000 tablets Rx only Valsartan and Hydrochlorothiazide Tablets USP, 320/25 mg NDC 70771-1489-0 in bottle of 1000 tablets 1000 tablets Rx only 80 mg/ 12.5 mg 160 mg/ 12.5 mg 160 mg/ 25 mg 320 mg/ 12.5 mg 320 mg/ 25 mg"],"set_id":"bd199010-1d85-4011-939c-4704ecfaba1f","spl_product_data_elements":["valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide VALSARTAN VALSARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 4000 SILICON DIOXIDE TALC TITANIUM DIOXIDE PINK OVAL 279 valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide VALSARTAN VALSARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HYPROMELLOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TITANIUM DIOXIDE TALC ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CROSPOVIDONE FERROSOFERRIC OXIDE POLYETHYLENE GLYCOL 4000 brownish red OVAL 280 valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide VALSARTAN VALSARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HYPROMELLOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TITANIUM DIOXIDE TALC ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CROSPOVIDONE FERROSOFERRIC OXIDE POLYETHYLENE GLYCOL 4000 BROWN oval 282 valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide VALSARTAN VALSARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 4000 SILICON DIOXIDE TALC TITANIUM DIOXIDE pink oval 281 valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide VALSARTAN VALSARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HYPROMELLOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 4000 TITANIUM DIOXIDE TALC ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CROSPOVIDONE FERROSOFERRIC OXIDE BROWN OVAL 283"],"spl_unclassified_section":[""],"version":"4"}