FDA.reportPublic FDA data

ENTRESTO

Product NDC
0078-0777
11-digit product format
000780777
Labeler code
0078
Product ID
0078-0777_a0cb416b-6ead-4623-949b-ee3d9dd1143a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sacubitril and Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA207620
Marketing category
NDA
Marketing start
2015-07-07
Substance
SACUBITRIL; VALSARTAN
Active strength
49; 51 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ENTRESTO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SACUBITRIL49 mg/1
VALSARTAN51 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii17ERJ0MKGI, 80M03YXJ7I
Rxcui1656340, 1656346, 1656349, 1656351, 1656354, 1656356, 2679793, 2679797, 2679800, 2679802

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
e7dfdaab-7cf9-4f89-804c-eff5108d94d1Product name920250305
b6abae2f-ee27-47bc-b150-54dc8d969483Product name220250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0078-0777-202024-02-02C16284748780-11030e365-17ba-111a-e063-dadaa90a10e2These 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
0078-0777-202024-02-02C16284748780-11030e365-17ba-111a-e063-dadaa90a10e2These 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
0078-0777-352024-02-02C16284748780-11030e365-17ba-111a-e063-dadaa90a10e2These 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
0078-0777-352024-02-02C16284748780-11030e365-17ba-111a-e063-dadaa90a10e2These 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
0078-0777-672024-02-02C16284748780-11030e365-17ba-111a-e063-dadaa90a10e2These 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
0078-0777-672024-02-02C16284748780-11030e365-17ba-111a-e063-dadaa90a10e2These 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
0078-0777-202024-01-30C16284748780-11030e365-17ba-111a-e063-dadaa90a10e2These 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
0078-0777-202024-01-30C16284748780-11030e365-17ba-111a-e063-dadaa90a10e2These 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
0078-0777-352024-01-30C16284748780-11030e365-17ba-111a-e063-dadaa90a10e2These 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
0078-0777-352024-01-30C16284748780-11030e365-17ba-111a-e063-dadaa90a10e2These 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
0078-0777-672024-01-30C16284748780-11030e365-17ba-111a-e063-dadaa90a10e2These 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
0078-0777-672024-01-30C16284748780-11030e365-17ba-111a-e063-dadaa90a10e2These 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
0078-0777-20ENTRESTO60 in 1 BOTTLETABLET, FILM COATED6024
0078-0777-35ENTRESTO100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10024
0078-0777-61ENTRESTO1 in 1 BLISTER PACKTABLET, FILM COATED124
0078-0777-67ENTRESTO180 in 1 BOTTLETABLET, FILM COATED18024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0777-20EA - Each0078-0777839783a1-8e3a-44bd-af90-0a940672e33712015-08-04
0078-0777-35EA - Each0078-077754cba86a-7e31-4577-8316-18d38c67a08812015-08-04
0078-0777-61EA - Each0078-0777d9edeefd-2ed7-4480-bc85-08d68c91828a12015-08-04
0078-0777-67EA - Each0078-0777168a3e56-65fb-4f5b-be05-fe0d8dde5d8512015-08-04

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0777ENTRESTO (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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656346Entresto 24 MG / 26 MG Oral TabletPSN000dc81d-ab91-450c-8eae-8eb74e72296f24
1656351Entresto 49 MG / 51 MG Oral TabletPSN000dc81d-ab91-450c-8eae-8eb74e72296f24
1656356Entresto 97 MG / 103 MG Oral TabletPSN000dc81d-ab91-450c-8eae-8eb74e72296f24
2679797Entresto Sprinkle 15 MG / 16 MG Oral PelletPSN000dc81d-ab91-450c-8eae-8eb74e72296f24
2679802Entresto Sprinkle 6 MG / 6 MG Oral PelletPSN000dc81d-ab91-450c-8eae-8eb74e72296f24
2679793sacubitril 15 MG / valsartan 16 MG Oral PelletPSN000dc81d-ab91-450c-8eae-8eb74e72296f24
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN000dc81d-ab91-450c-8eae-8eb74e72296f24
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN000dc81d-ab91-450c-8eae-8eb74e72296f24
2679800sacubitril 6 MG / valsartan 6 MG Oral PelletPSN000dc81d-ab91-450c-8eae-8eb74e72296f24
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN000dc81d-ab91-450c-8eae-8eb74e72296f24
2679797sacubitril 15 MG / valsartan 16 MG Oral Pellet [Entresto]SBD000dc81d-ab91-450c-8eae-8eb74e72296f24
1656346sacubitril 24 MG / valsartan 26 MG Oral Tablet [Entresto]SBD000dc81d-ab91-450c-8eae-8eb74e72296f24
1656351sacubitril 49 MG / valsartan 51 MG Oral Tablet [Entresto]SBD000dc81d-ab91-450c-8eae-8eb74e72296f24
2679802sacubitril 6 MG / valsartan 6 MG Oral Pellet [Entresto]SBD000dc81d-ab91-450c-8eae-8eb74e72296f24
1656356sacubitril 97 MG / valsartan 103 MG Oral Tablet [Entresto]SBD000dc81d-ab91-450c-8eae-8eb74e72296f24
2679793sacubitril 15 MG / valsartan 16 MG Oral PelletSCD000dc81d-ab91-450c-8eae-8eb74e72296f24
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD000dc81d-ab91-450c-8eae-8eb74e72296f24
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD000dc81d-ab91-450c-8eae-8eb74e72296f24
2679800sacubitril 6 MG / valsartan 6 MG Oral PelletSCD000dc81d-ab91-450c-8eae-8eb74e72296f24
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD000dc81d-ab91-450c-8eae-8eb74e72296f24
1656346Entresto (sacubitril 24 MG / valsartan 26 MG) Oral TabletSY000dc81d-ab91-450c-8eae-8eb74e72296f24
1656351Entresto (sacubitril 49 MG / valsartan 51 MG) Oral TabletSY000dc81d-ab91-450c-8eae-8eb74e72296f24
1656356Entresto (sacubitril 97 MG / valsartan 103 MG) Oral TabletSY000dc81d-ab91-450c-8eae-8eb74e72296f24
2679797Entresto Sprinkle (sacubitril 15 MG / valsartan 16 MG) Oral PelletSY000dc81d-ab91-450c-8eae-8eb74e72296f24
2679802Entresto Sprinkle (sacubitril 6 MG / valsartan 6 MG) Oral PelletSY000dc81d-ab91-450c-8eae-8eb74e72296f24
2679793sacubitril 15 MG / valsartan 16 MG Oral PelletSY000dc81d-ab91-450c-8eae-8eb74e72296f24
2679800sacubitril 6 MG / valsartan 6 MG Oral PelletSY000dc81d-ab91-450c-8eae-8eb74e72296f24
1656351Entresto 49 MG / 51 MG Oral TabletPSN14bf8041-0b7f-9acb-e063-6294a90a82561
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN14bf8041-0b7f-9acb-e063-6294a90a82561
1656351sacubitril 49 MG / valsartan 51 MG Oral Tablet [Entresto]SBD14bf8041-0b7f-9acb-e063-6294a90a82561
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD14bf8041-0b7f-9acb-e063-6294a90a82561
1656351Entresto (sacubitril 49 MG / valsartan 51 MG) Oral TabletSY14bf8041-0b7f-9acb-e063-6294a90a82561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0777-200007807772060 TABLET, FILM COATED in 1 BOTTLE (0078-0777-20) 2015-07-070000-00-00NoNoCurrent
0078-0777-3500078077735100 in 1 BOX, UNIT-DOSEHistorical
0078-0777-61000780777611 in 1 BLISTER PACKHistorical
0078-0777-6700078077767180 TABLET, FILM COATED in 1 BOTTLE (0078-0777-67) 2015-07-070000-00-00NoNoCurrent