FDA.reportPublic FDA data

NDC 0078-0471-67 - Diovan HCT

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0078-0471
Requested NDC
0078-0471-67
Package NDCs from labels
0078-0471-34, 0078-0471-61, 0078-0471-15, 0078-0471-67
Manufacturer
Novartis Pharmaceuticals Corporation
Effective date
2026-02-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diovan HCT - Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation2026-02-13HUMAN PRESCRIPTION DRUG LABEL
Diovan HCT - Physicians Total Care, Inc.Physicians Total Care, Inc.2012-01-09HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0471-15Diovan HCT30 in 1 BOX, UNIT-DOSETABLET, FILM COATED3034
0078-0471-34Diovan HCT90 in 1 BOTTLETABLET, FILM COATED9034
0078-0471-61Diovan HCT1 in 1 BLISTER PACKTABLET, FILM COATED134

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0471DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]32Current NDC, Legacy NDC, 3 package rows20250110_d76a0419-05ee-437e-884c-65807aea9569.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0471-15EA - Each0078-047172d3f9a3-e994-4f21-a79a-c6948c5298a412012-07-24
0078-0471-34EA - Each0078-047112ee532e-34a7-4488-b5a6-a52651e9048112012-07-24
0078-0471-67EA - Each0078-0471e01c07c5-cf61-4e8e-bc34-5468cb78ca8d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
VALSARTANACTIVE INGREDIENT80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
VALSARTANACTIVE MOIETY80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
TALCINACTIVE INGREDIENT7SEV7J4R1UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
VALSARTANACTIVE INGREDIENT80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
VALSARTANACTIVE MOIETY80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 169 · 3,364 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.5ee165a3-39a4-4d12-aff2-a6fb3309ce392026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAvKARE1b303136-dccd-178b-e063-6394a90a35f82026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.7dc3414b-dcb5-4b11-bca7-c0fa3f474aea2026-09-03Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEUmedica Laboratories USA Inc.55d6aee1-01ca-4791-8404-386664b4ab072026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
ValsartanVALSARTANAphena Pharma Solutions - Tennessee, LLC5a816ea6-2645-bd6e-e063-6294a90a908b2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 80M03YXJ7I
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEEdenbridge Pharmaceuticals LLC.295532b5-65c8-40c3-8d27-cfd334d128022026-08-28Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEREMEDYREPACK INC.57ffeef7-bfa8-4f92-aadc-23cd000226072026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.f20fd735-30c7-4f89-8ceb-b6186646eea62026-08-27Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
valsartanVALSARTANJubilant Cadista Pharmaceuticals Inc.9402b022-5809-4251-dfef-54f6ef5723fe2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 80M03YXJ7I
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.8e0683e2-5473-4246-97ae-b71c21c39ac72026-08-26Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.