exforge hct (0078-0563) | FunFoxMeds NDC

Drug Facts

Product Profile

Brand Name exforge hct

Generic Name amlodipine valsartan and hydrochlorothiazide

Labeler novartis pharmaceuticals corporation

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amlodipine besylate 10 mg/1, hydrochlorothiazide 25 mg/1, valsartan 320 mg/1

Manufacturer

Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0563

Product ID 0078-0563_e10fea42-c6e7-4584-9a0a-0709c5323cd8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA022314

Listing Expiration 2026-12-31

Marketing Start 2009-04-04

Pharmacologic Class

Established (EPC)

thiazide diuretic [epc] angiotensin 2 receptor blocker [epc]

Mechanism of Action

angiotensin 2 receptor antagonists [moa]

Chemical Structure

thiazides [cs]

Physiologic Effect

increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780563

Hyphenated Format 0078-0563

Supplemental Identifiers

RxCUI

848131 848134 848135 848139 848140 848144 848145 848149 848151 848155

UNII

0J48LPH2TH 864V2Q084H 80M03YXJ7I

NUI

N0000175359 N0000175419 M0471776 N0000000070 N0000175561

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name exforge hct (source: ndc)

Generic Name amlodipine valsartan and hydrochlorothiazide (source: ndc)

Application Number NDA022314 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
25 mg/1
320 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (0078-0563-15)

source: ndc

Packages (1)

0078-0563-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0563-15)

Ingredients (3)

amlodipine besylate (10 mg/1) hydrochlorothiazide (25 mg/1) valsartan (320 mg/1)

Linked Drug Pages (1)

Exforge HCT ndc-match (0.9)

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 (0078-0563-15)", "package_ndc": "0078-0563-15", "marketing_start_date": "20090404"}], "brand_name": "Exforge HCT", "product_id": "0078-0563_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": "0078-0563", "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": "25 mg/1"}, {"name": "VALSARTAN", "strength": "320 mg/1"}], "application_number": "NDA022314", "marketing_category": "NDA", "marketing_start_date": "20090404", "listing_expiration_date": "20261231"}