{"effective_time":"20221107","id":"9d6e36f0-a9e4-4b66-997a-fd5f8e4e1cf7","openfda":{"application_number":["ANDA215666"],"brand_name":["Bisoprolol Fumarate and Hydrochlorothiazide"],"generic_name":["BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000175359","N0000175419","M0471776"],"package_ndc":["70771-1760-3","70771-1760-1","70771-1760-5","70771-1761-3","70771-1761-1","70771-1761-5","70771-1762-3","70771-1762-1","70771-1762-5"],"pharm_class_cs":["Thiazides [CS]"],"pharm_class_epc":["Thiazide Diuretic [EPC]"],"pharm_class_pe":["Increased Diuresis [PE]"],"product_ndc":["70771-1760","70771-1761","70771-1762"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["854908","854916","854919"],"spl_id":["9d6e36f0-a9e4-4b66-997a-fd5f8e4e1cf7"],"spl_set_id":["35ed3030-a9b3-4e4e-99cd-6d5c31ad22fa"],"substance_name":["BISOPROLOL FUMARATE","HYDROCHLOROTHIAZIDE"],"unii":["UR59KN573L","0J48LPH2TH"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1760-3 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 2.5 mg/6.25 mg 30 Tablets Unit-of-Use Rx only NDC 70771-1761-3 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 5 mg/6.25 mg 30 Tablets Unit-of-Use Rx only NDC 70771-1762-3 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 10 mg/6.25 mg 30 Tablets Unit-of-Use Rx only 2.5 mg/6.25 mg 5 mg/6.25 mg 10 mg/6.25 mg"],"set_id":"35ed3030-a9b3-4e4e-99cd-6d5c31ad22fa","spl_product_data_elements":["Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide BISOPROLOL FUMARATE BISOPROLOL HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE MICROCRYSTALLINE CELLULOSE 102 BUTYLATED HYDROXYANISOLE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE SILICON DIOXIDE CROSPOVIDONE (35 .MU.M) HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 8000 FERRIC OXIDE YELLOW FERRIC OXIDE RED with occasional greyish to black speckles round 113 Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide BISOPROLOL FUMARATE BISOPROLOL HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE MICROCRYSTALLINE CELLULOSE 102 BUTYLATED HYDROXYANISOLE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE SILICON DIOXIDE CROSPOVIDONE (35 .MU.M) HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 8000 FD&C RED NO. 40 D&C YELLOW NO. 10 ALUMINUM LAKE ALUMINUM OXIDE light pink to pink round 114 Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide BISOPROLOL FUMARATE BISOPROLOL HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE MICROCRYSTALLINE CELLULOSE 102 BUTYLATED HYDROXYANISOLE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE SILICON DIOXIDE CROSPOVIDONE (35 .MU.M) HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 8000 with occasional greyish to black speckles round 115"],"spl_unclassified_section":[""],"version":"1"}