FDA.reportPublic FDA data

NDC 0078-0659-61 - ENTRESTO

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
0078-0659
Requested NDC
0078-0659-61
Package NDCs from labels
0078-0659-20, 0078-0659-67, 0078-0659-61, 0078-0659-35
Manufacturer
Novartis Pharmaceuticals Corporation
Effective date
2026-07-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ENTRESTO - Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation2026-07-06HUMAN PRESCRIPTION DRUG LABEL
ENTRESTO - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2025-06-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0078-0659-202024-02-02These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-202024-02-02These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-202024-02-02These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-352024-02-02These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-352024-02-02These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-352024-02-02These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-672024-02-02These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-672024-02-02These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-672024-02-02These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-202024-01-30These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-202024-01-30These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-202024-01-30These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-352024-01-30These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-352024-01-30These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-352024-01-30These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-672024-01-30These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-672024-01-30These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
0078-0659-672024-01-30These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0659-20ENTRESTO60 in 1 BOTTLETABLET, FILM COATED6024
0078-0659-35ENTRESTO100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10024
0078-0659-61ENTRESTO1 in 1 BLISTER PACKTABLET, FILM COATED124
0078-0659-67ENTRESTO180 in 1 BOTTLETABLET, FILM COATED18024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0659ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED ENTRESTO (SACUBITRIL AND VALSARTAN) PELLET [NOVARTIS PHARMACEUTICALS CORPORATION]22Current NDC, Legacy NDC, 4 package rows20250122_000dc81d-ab91-450c-8eae-8eb74e72296f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0659-20EA - Each0078-06597c5b21f8-d9cf-4f03-8717-96b3165fe44012015-08-04
0078-0659-35EA - Each0078-06590ca33dbf-db3c-409c-9c71-e2527d9c359b12015-08-04
0078-0659-61EA - Each0078-0659e24490f2-83aa-400a-919c-93e8a50c672b12015-08-04
0078-0659-67EA - Each0078-06597946074b-476c-4d9e-8740-24cd7031c98512015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SACUBITRILACTIVE INGREDIENT17ERJ0MKGIENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
VALSARTANACTIVE INGREDIENT80M03YXJ7IENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
SACUBITRILACTIVE MOIETY17ERJ0MKGIENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
VALSARTANACTIVE MOIETY80M03YXJ7IENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
TALCINACTIVE INGREDIENT7SEV7J4R1UENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]2

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 149 · 2,971 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
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
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
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
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
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsAMMONIAShenzhen Finona Information Technology Co., Ltd3874ec89-0f1d-87b9-e063-6394a90a300a2026-08-24WarningsExact identifier
unii: 5138Q19F1X
ValsartanVALSARTANAphena Pharma Solutions - Tennessee, LLC59d3db05-2d63-9dbf-e063-6394a90a8dd32026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 80M03YXJ7I
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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