Package 0078-0561-15

Brand: exforge hct

Generic: amlodipine valsartan and hydrochlorothiazide
NDC Package

Package Facts

Identity

Package NDC 0078-0561-15
Digits Only 0078056115
Product NDC 0078-0561
Description

30 TABLET, FILM COATED in 1 BOTTLE (0078-0561-15)

Marketing

Marketing Status
Marketed Since 2009-04-04
Brand exforge hct
Generic amlodipine valsartan and hydrochlorothiazide
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "e10fea42-c6e7-4584-9a0a-0709c5323cd8", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "unii": ["0J48LPH2TH", "864V2Q084H", "80M03YXJ7I"], "rxcui": ["848131", "848134", "848135", "848139", "848140", "848144", "848145", "848149", "848151", "848155"], "spl_set_id": ["18d7820d-471f-4ee2-9ec6-25d8d27c77de"], "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": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0078-0561-15)", "package_ndc": "0078-0561-15", "marketing_start_date": "20090404"}], "brand_name": "Exforge HCT", "product_id": "0078-0561_e10fea42-c6e7-4584-9a0a-0709c5323cd8", "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": "0078-0561", "generic_name": "amlodipine valsartan and hydrochlorothiazide", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Exforge HCT", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "NDA022314", "marketing_category": "NDA", "marketing_start_date": "20090404", "listing_expiration_date": "20261231"}