FDA.reportPublic FDA data

sacubitril and valsartan

Product NDC
70748-195
11-digit product format
707480195
Labeler code
70748
Product ID
70748-195_e8c2bfce-cd97-4f79-a4e7-0c9ed648d7fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sacubitril and valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA213808
Marketing category
ANDA
Marketing start
2025-07-29
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
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
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70748-195-07sacubitril and valsartan60 in 1 BOTTLETABLET, FILM COATED6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70748-195-07EA - Each70748-195a48f5a4f-305f-4059-bf53-c63a31fb8d8912025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN76cbb87b-6356-4ead-af7f-faffb6e7974311
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN76cbb87b-6356-4ead-af7f-faffb6e7974311
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN76cbb87b-6356-4ead-af7f-faffb6e7974311
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD76cbb87b-6356-4ead-af7f-faffb6e7974311
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD76cbb87b-6356-4ead-af7f-faffb6e7974311
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD76cbb87b-6356-4ead-af7f-faffb6e7974311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70748-195-077074801950760 TABLET, FILM COATED in 1 BOTTLE (70748-195-07) 2025-07-29NoNoCurrent