FDA.reportPublic FDA data

sacubitril 97 MG / valsartan 103 MG Oral Tablet [Entresto]

RxCUI
1656356
RxNorm name
sacubitril 97 MG / valsartan 103 MG Oral Tablet [Entresto]
Display name
ENTRESTO (Oral Pill)
Full name
sacubitril 97 MG / valsartan 103 MG Oral Tablet [Entresto]
Term type
SBD
Status
Active
Strength
97-103 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-29 07:11:24

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
082015
Active start
082015
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
sacubitril97 MG / 1 EACHsacubitrilsacubitril
valsartan103 MG / 1 EACHvalsartanvalsartan

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
sacubitril1656328
valsartan69749

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STREntresto (sacubitril 97 MG / valsartan 103 MG) Oral Tablet1NAMES
RxNorm Namesacubitril 97 MG / valsartan 103 MG Oral Tablet [Entresto]1NAMES
RxNorm SynonymEntresto (sacubitril 97 MG / valsartan 103 MG) Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI16563561CODES
MMSL_CODEBD303401CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0078-0696-200078-0696ENTRESTO Sacubitril and ValsartanNovartis Pharmaceuticals CorporationNDA207620
0078-0696-670078-0696ENTRESTO Sacubitril and ValsartanNovartis Pharmaceuticals CorporationNDA207620
71610-807-3771610-807ENTRESTO Sacubitril and ValsartanAphena Pharma Solutions - Tennessee, LLCNDA207620

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA2076200078-0696ENTRESTO Sacubitril and ValsartanNDANovartis Pharmaceuticals Corporation

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 5 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00078069620rxnav_ndcsyes
00078069635rxnav_ndcsyes
00078069661rxnav_ndcsyes
00078069667rxnav_ndcsyes
71610080737rxnav_ndcsyes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENTRESTOSACUBITRIL AND VALSARTANNovartis Pharmaceuticals Corporation000dc81d-ab91-450c-8eae-8eb74e72296f2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0078-0696-20
ndc (package): 0078-0696-67
ndc (product): 0078-0696
ndc11 (package): 00078069667
ndc11 (package): 00078069620
ndc11 (package): 00078069635
ndc11 (package): 00078069661
rxcui: 1656356
ENTRESTOSACUBITRIL AND VALSARTANAphena Pharma Solutions - Tennessee, LLC14bfc60a-9ddf-cac7-e063-6294a90a597b2024-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 71610-807-37
ndc (product): 71610-807
ndc11 (package): 71610080737
rxcui: 1656356

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
000dc81d-ab91-450c-8eae-8eb74e72296fEntresto 97 MG / 103 MG Oral Tablet [PSN] · sacubitril 97 MG / valsartan 103 MG Oral Tablet [Entresto] [SBD] · Entresto (sacubitril 97 MG / valsartan 103 MG) Oral Tablet [SY]324These 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: 201520251029
14bfc60a-9ddf-cac7-e063-6294a90a597bEntresto 97 MG / 103 MG Oral Tablet [PSN] · sacubitril 97 MG / valsartan 103 MG Oral Tablet [Entresto] [SBD] · Entresto (sacubitril 97 MG / valsartan 103 MG) Oral Tablet [SY]31These 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 Initial U.S. Approval: 201520240328

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
000dc81d-ab91-450c-8eae-8eb74e72296fThese 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: 2015Novartis Pharmaceuticals Corporation20260706
000dc81d-ab91-450c-8eae-8eb74e72296fThese 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: 2015Novartis Pharmaceuticals Corporation20251029
000dc81d-ab91-450c-8eae-8eb74e72296fThese 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: 2015Novartis Pharmaceuticals Corporation20250812
14bfc60a-9ddf-cac7-e063-6294a90a597bThese 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 Initial U.S. Approval: 2015Aphena Pharma Solutions - Tennessee, LLC20240328

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC09DXAngiotensin II receptor blockers (ARBs), other combinationsATC1-4sacubitril / valsartan
ATCC09CAAngiotensin II receptor blockers (ARBs), plainATC1-4valsartan
FDASPLN0000175561Angiotensin 2 Receptor BlockerEPChas_epcvalsartan
FDASPLN0000000070Angiotensin 2 Receptor AntagonistsMOAhas_moavalsartan
MEDRTD000613AminobutyratesCHEMhas_ingredientsacubitril
MEDRTD001713Biphenyl CompoundsCHEMhas_ingredientsacubitril
MEDRTD000068756ValsartanCHEMhas_ingredientvalsartan
MEDRTD003928Diabetic NephropathiesDISEASEmay_treatvalsartan
MEDRTD004342Drug HypersensitivityDISEASEci_withsacubitril
MEDRTD004342Drug HypersensitivityDISEASEci_withvalsartan
MEDRTD006333Heart FailureDISEASEmay_preventsacubitril
MEDRTD006333Heart FailureDISEASEmay_treatvalsartan
MEDRTD006929HyperaldosteronismDISEASEci_withvalsartan
MEDRTD006973HypertensionDISEASEmay_treatvalsartan
MEDRTD007022HypotensionDISEASEci_withvalsartan
MEDRTD011247PregnancyDISEASEci_withvalsartan
MEDRTD018487Ventricular Dysfunction, LeftDISEASEmay_treatvalsartan
MEDRTN0000000070Angiotensin 2 Receptor AntagonistsMOAhas_moavalsartan
MEDRTN0000191727Neprilysin InhibitorsMOAhas_moasacubitril
MEDRTN0000178477Decreased Blood PressurePEhas_pevalsartan
MEDRTN0000008669Decreased Intravascular VolumePEhas_pevalsartan
MEDRTN0000008731Decreased Mineralocorticoid SecretionPEhas_pevalsartan
MEDRTN0000008859Decreased Renal K+ ExcretionPEhas_pevalsartan
MEDRTN0000009553Increased Renal Na+ ExcretionPEhas_pevalsartan
MEDRTN0000009825Renal Arterial VasoconstrictionPEci_pevalsartan
MEDRTN0000009826Renal Arterial VasodilationPEhas_pevalsartan

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH97 MG / 103 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA207620
NAMESPrescribable SynonymEntresto 97 MG / 103 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon