FDA.reportPublic FDA data

ENTRESTO

Product NDC
71610-810
11-digit product format
716100810
Labeler code
71610
Product ID
71610-810_3880b55a-6fa6-06ed-e063-6294a90a548b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sacubitril and Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA207620
Marketing category
NDA
Marketing start
2015-07-07
Substance
SACUBITRIL; VALSARTAN
Active strength
24; 26 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
SACUBITRIL24 mg/1
VALSARTAN26 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii17ERJ0MKGI, 80M03YXJ7I
Rxcui1656340, 1656346

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-810-32ENTRESTO780 in 1 BOTTLETABLET, FILM COATED7802
71610-810-88ENTRESTO900 in 1 BOTTLETABLET, FILM COATED9002
71610-810-89ENTRESTO720 in 1 BOTTLETABLET, FILM COATED7202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-810-32EA - Each71610-8104847344e-6d97-49bd-9849-099f8b627fed12024-05-16
71610-810-88EA - Each71610-810da22925f-05a2-4f81-af60-dcdf093d4bd712025-08-11
71610-810-89EA - Each71610-810b9ffe006-0184-4ae5-912e-b3209ea129e912025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-810ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 3 package rows20240405_152335bf-12c4-28e6-e063-6294a90ac20f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656346Entresto 24 MG / 26 MG Oral TabletPSN152335bf-12c4-28e6-e063-6294a90ac20f2
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN152335bf-12c4-28e6-e063-6294a90ac20f2
1656346sacubitril 24 MG / valsartan 26 MG Oral Tablet [Entresto]SBD152335bf-12c4-28e6-e063-6294a90ac20f2
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD152335bf-12c4-28e6-e063-6294a90ac20f2
1656346Entresto (sacubitril 24 MG / valsartan 26 MG) Oral TabletSY152335bf-12c4-28e6-e063-6294a90ac20f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-810-3271610081032780 TABLET, FILM COATED in 1 BOTTLE (71610-810-32) 2024-04-01NoNoCurrent
71610-810-8871610081088900 TABLET, FILM COATED in 1 BOTTLE (71610-810-88) 2025-06-23NoNoCurrent
71610-810-8971610081089720 TABLET, FILM COATED in 1 BOTTLE (71610-810-89) 2025-06-23NoNoCurrent