FDA.reportPublic FDA data

sacubitril and valsartan

Product NDC
70771-1922
11-digit product format
707711922
Labeler code
70771
Product ID
70771-1922_f0d8c298-2823-4537-ae02-c43da2c66e67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sacubitril and valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA213719
Marketing category
ANDA
Marketing start
2025-07-08
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
70771-1922-2sacubitril and valsartan10 in 1 BLISTER PACKTABLET101
70771-1922-4sacubitril and valsartan10 in 1 CARTONTABLET101
70771-1922-6sacubitril and valsartan60 in 1 BOTTLETABLET601
70771-1922-8sacubitril and valsartan180 in 1 BOTTLETABLET1801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN4c871c01-0564-411f-87e2-478aa42503cf1
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN4c871c01-0564-411f-87e2-478aa42503cf1
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN4c871c01-0564-411f-87e2-478aa42503cf1
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD4c871c01-0564-411f-87e2-478aa42503cf1
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD4c871c01-0564-411f-87e2-478aa42503cf1
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD4c871c01-0564-411f-87e2-478aa42503cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1922-27077119220210 in 1 BLISTER PACKHistorical
70771-1922-47077119220410 BLISTER PACK in 1 CARTON (70771-1922-4) / 10 TABLET in 1 BLISTER PACK (70771-1922-2) 10 blister pack2025-07-08NoNoHistorical
70771-1922-67077119220660 TABLET in 1 BOTTLE (70771-1922-6) 60 tablet2025-07-08NoNoHistorical
70771-1922-870771192208180 TABLET in 1 BOTTLE (70771-1922-8) 180 tablet2025-07-08NoNoHistorical