diovan hct

Generic: valsartan and hydrochlorothiazide

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name diovan hct
Generic Name valsartan and hydrochlorothiazide
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydrochlorothiazide 25 mg/1, valsartan 160 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0383
Product ID 0078-0383_c42c209a-1ad4-43a9-a4f6-33a435fb44e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020818
Listing Expiration 2027-12-31
Marketing Start 1998-03-06

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 00780383
Hyphenated Format 0078-0383

Supplemental Identifiers

RxCUI
200284 200285 349353 636042 636045 809014 809018 809022 809026 809030
UNII
0J48LPH2TH 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 diovan hct (source: ndc)
Generic Name valsartan and hydrochlorothiazide (source: ndc)
Application Number NDA020818 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 160 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (0078-0383-34)
source: ndc

Packages (1)

0078-0383-34 90 TABLET, FILM COATED in 1 BOTTLE (0078-0383-34)

Ingredients (2)

hydrochlorothiazide (25 mg/1) valsartan (160 mg/1)

Linked Drug Pages (1)

Diovan HCT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c42c209a-1ad4-43a9-a4f6-33a435fb44e7", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "unii": ["0J48LPH2TH", "80M03YXJ7I"], "rxcui": ["200284", "200285", "349353", "636042", "636045", "809014", "809018", "809022", "809026", "809030"], "spl_set_id": ["d76a0419-05ee-437e-884c-65807aea9569"], "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": "90 TABLET, FILM COATED in 1 BOTTLE (0078-0383-34)", "package_ndc": "0078-0383-34", "marketing_start_date": "19980306"}], "brand_name": "Diovan HCT", "product_id": "0078-0383_c42c209a-1ad4-43a9-a4f6-33a435fb44e7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "0078-0383", "generic_name": "valsartan and hydrochlorothiazide", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diovan HCT", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "NDA020818", "marketing_category": "NDA", "marketing_start_date": "19980306", "listing_expiration_date": "20271231"}