FDA.reportPublic FDA data

Sacubitril and Valsartan

Product NDC
72865-310
11-digit product format
728650310
Labeler code
72865
Product ID
72865-310_c4dddf41-2e19-4fd1-8f2a-6b33a804ed40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sacubitril and Valsartan
Dosage form
TABLET
Route
ORAL
Labeler
XLCare Pharmaceuticals Inc
Application
ANDA213728
Marketing category
ANDA
Marketing start
2025-09-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sacubitril and Valsartan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SACUBITRIL24 mg/1
VALSARTAN26 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii17ERJ0MKGI, 80M03YXJ7I
Rxcui1656340, 1656349, 1656354

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
72865-310-10Sacubitril and Valsartan1000 in 1 BOTTLETABLET10002
72865-310-18Sacubitril and Valsartan180 in 1 BOTTLETABLET1802
72865-310-60Sacubitril and Valsartan60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-310-18EA - Each72865-31007ef7f85-7b08-41a9-bdce-4d7460ec7dfb12026-02-05
72865-310-60EA - Each72865-31006224424-37a2-432e-971c-60c9008ce9d712026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN064a7c51-de30-4759-8210-e18438e6a1872
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN064a7c51-de30-4759-8210-e18438e6a1872
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN064a7c51-de30-4759-8210-e18438e6a1872
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD064a7c51-de30-4759-8210-e18438e6a1872
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD064a7c51-de30-4759-8210-e18438e6a1872
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD064a7c51-de30-4759-8210-e18438e6a1872
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN4870fbeb-ce93-7953-e063-6294a90a61421
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD4870fbeb-ce93-7953-e063-6294a90a61421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-310-10728650310101000 TABLET in 1 BOTTLE (72865-310-10) 1000 tablet2026-04-01NoNoCurrent
72865-310-1872865031018180 TABLET in 1 BOTTLE (72865-310-18) 180 tablet2025-09-30NoNoCurrent
72865-310-607286503106060 TABLET in 1 BOTTLE (72865-310-60) 60 tablet2025-09-30NoNoCurrent