FDA.reportPublic FDA data

ENTRESTO

Product NDC
71610-807
11-digit product format
716100807
Labeler code
71610
Product ID
71610-807_14bfc625-3f5d-cdde-e063-6294a90afeae
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
97; 103 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
SACUBITRIL97 mg/1
VALSARTAN103 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii17ERJ0MKGI, 80M03YXJ7I
Rxcui1656354, 1656356

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
71610-807-37ENTRESTO3120 in 1 BOTTLETABLET, FILM COATED31201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-807-37EA - Each71610-807cc0bd67b-50ca-4e6c-a25d-de0bbd24992612024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-807ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 1 package rows20240330_14bfc60a-9ddf-cac7-e063-6294a90a597b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656356Entresto 97 MG / 103 MG Oral TabletPSN14bfc60a-9ddf-cac7-e063-6294a90a597b1
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN14bfc60a-9ddf-cac7-e063-6294a90a597b1
1656356sacubitril 97 MG / valsartan 103 MG Oral Tablet [Entresto]SBD14bfc60a-9ddf-cac7-e063-6294a90a597b1
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD14bfc60a-9ddf-cac7-e063-6294a90a597b1
1656356Entresto (sacubitril 97 MG / valsartan 103 MG) Oral TabletSY14bfc60a-9ddf-cac7-e063-6294a90a597b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-807-37716100807373120 TABLET, FILM COATED in 1 BOTTLE (71610-807-37) 2024-03-22NoNoHistorical