Package 64380-197-02

Brand: amlodipine, valsartan, hydrochlorothiazide

Generic: amlodipine besylate valsartan hydrochlorothiazide
NDC Package

Package Facts

Identity

Package NDC 64380-197-02
Digits Only 6438019702
Product NDC 64380-197
Product ID 64380-197_6c98cab6-e7ba-42ba-adf9-71fa67c0a403
Description

90 TABLET, FILM COATED in 1 BOTTLE (64380-197-02)

Marketing

Marketing Status
Marketed Since 2022-06-27
Brand amlodipine, valsartan, hydrochlorothiazide
Generic amlodipine besylate valsartan hydrochlorothiazide
Sample Package No

Linked Drug Pages (1)

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6c98cab6-e7ba-42ba-adf9-71fa67c0a403", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0364380197010", "0364380199014", "0364380200017", "0364380201014"], "unii": ["0J48LPH2TH", "864V2Q084H", "80M03YXJ7I"], "rxcui": ["848131", "848135", "848140", "848145", "848151"], "spl_set_id": ["9b76e441-e6a5-4036-8276-b7788ade5c44"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (64380-197-01)", "package_ndc": "64380-197-01", "marketing_start_date": "20220627"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (64380-197-02)", "package_ndc": "64380-197-02", "marketing_start_date": "20220627"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (64380-197-03)", "package_ndc": "64380-197-03", "marketing_start_date": "20220627"}], "brand_name": "AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE", "product_id": "64380-197_6c98cab6-e7ba-42ba-adf9-71fa67c0a403", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "64380-197", "generic_name": "amlodipine besylate valsartan hydrochlorothiazide", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA201087", "marketing_category": "ANDA", "marketing_start_date": "20220627", "listing_expiration_date": "20261231"}