FDA.reportPublic FDA data

Sacubitril and Valsartan

Product NDC
70377-032
11-digit product format
703770032
Labeler code
70377
Product ID
70377-032_600f67e2-7ccf-65d9-012c-e7ba9b8a089f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sacubitril and Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Biocon Pharma Inc.
Application
ANDA213680
Marketing category
ANDA
Marketing start
2025-07-17
Substance
SACUBITRIL; VALSARTAN
Active strength
49; 51 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
Sacubitril and Valsartan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SACUBITRIL49 mg/1
VALSARTAN51 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
70377-032-11Sacubitril and Valsartan30 in 1 BOTTLETABLET, FILM COATED305
70377-032-12Sacubitril and Valsartan60 in 1 BOTTLETABLET, FILM COATED605
70377-032-13Sacubitril and Valsartan180 in 1 BOTTLETABLET, FILM COATED1805
70377-032-14Sacubitril and Valsartan500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN7de9b8e0-195a-b59e-7bbf-3e95c4096af95
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN7de9b8e0-195a-b59e-7bbf-3e95c4096af95
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN7de9b8e0-195a-b59e-7bbf-3e95c4096af95
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD7de9b8e0-195a-b59e-7bbf-3e95c4096af95
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD7de9b8e0-195a-b59e-7bbf-3e95c4096af95
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD7de9b8e0-195a-b59e-7bbf-3e95c4096af95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70377-032-117037700321130 TABLET, FILM COATED in 1 BOTTLE (70377-032-11) 2025-07-17NoNoCurrent
70377-032-127037700321260 TABLET, FILM COATED in 1 BOTTLE (70377-032-12) 2025-07-17NoNoCurrent
70377-032-1370377003213180 TABLET, FILM COATED in 1 BOTTLE (70377-032-13) 2025-07-17NoNoCurrent
70377-032-1470377003214500 TABLET, FILM COATED in 1 BOTTLE (70377-032-14) 2025-07-17NoNoCurrent