FDA.reportPublic FDA data

Sacubitril and Valsartan

Product NDC
73190-005
11-digit product format
731900005
Labeler code
73190
Product ID
73190-005_4c260039-9848-e878-e063-6294a90a3dcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sacubitril and Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA213748
Marketing category
ANDA
Marketing start
2025-01-21
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
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73190-005-10Sacubitril and Valsartan1000 in 1 BOTTLETABLET, FILM COATED10004
73190-005-18Sacubitril and Valsartan180 in 1 BOTTLETABLET, FILM COATED1804
73190-005-60Sacubitril and Valsartan60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73190-005-10EA - Each73190-0051dc117b3-a8d7-4a59-9b64-17b7c8a1c9c912026-04-20
73190-005-18EA - Each73190-0056446ccd9-8fab-4c97-8d98-e5313928c51912025-02-10
73190-005-60EA - Each73190-0057611cbab-501a-4127-9fce-24544ea4e75512025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73190-005SACUBITRIL AND VALSARTAN TABLET, FILM COATED [AVKARE]1Current NDC, 3 package rows20250122_2c39c326-34a2-b7f4-e063-6294a90a6732.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN2c39c326-34a2-b7f4-e063-6294a90a67324
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN2c39c326-34a2-b7f4-e063-6294a90a67324
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN2c39c326-34a2-b7f4-e063-6294a90a67324
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD2c39c326-34a2-b7f4-e063-6294a90a67324
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD2c39c326-34a2-b7f4-e063-6294a90a67324
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD2c39c326-34a2-b7f4-e063-6294a90a67324
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN3cfa68eb-6167-e7ed-e063-6294a90a27f62
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD3cfa68eb-6167-e7ed-e063-6294a90a27f62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73190-005-10731900005101000 TABLET, FILM COATED in 1 BOTTLE (73190-005-10) 2026-02-25NoNoCurrent
73190-005-1873190000518180 TABLET, FILM COATED in 1 BOTTLE (73190-005-18) 2025-01-21NoNoCurrent
73190-005-607319000056060 TABLET, FILM COATED in 1 BOTTLE (73190-005-60) 2025-01-21NoNoCurrent