FDA.reportPublic FDA data

Sacubitril and Valsartan

Product NDC
72865-312
11-digit product format
728650312
Labeler code
72865
Product ID
72865-312_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
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
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
SACUBITRIL97 mg/1
VALSARTAN103 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
72865-312-10Sacubitril and Valsartan1000 in 1 BOTTLETABLET10002
72865-312-18Sacubitril and Valsartan180 in 1 BOTTLETABLET1802
72865-312-60Sacubitril and Valsartan60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-312-18EA - Each72865-3127b155787-e39b-4a8f-9b6b-844a129b975d12026-02-05
72865-312-60EA - Each72865-3123c893e70-1524-4fbe-b17d-6d2db5468de412026-02-05

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
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN487102e3-f319-836b-e063-6394a90a44381
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD487102e3-f319-836b-e063-6394a90a44381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-312-10728650312101000 TABLET in 1 BOTTLE (72865-312-10) 1000 tablet2026-04-01NoNoCurrent
72865-312-1872865031218180 TABLET in 1 BOTTLE (72865-312-18) 180 tablet2025-09-30NoNoCurrent
72865-312-607286503126060 TABLET in 1 BOTTLE (72865-312-60) 60 tablet2025-09-30NoNoCurrent