FDA.reportPublic FDA data

Sacubitril and Valsartan

Product NDC
70954-975
11-digit product format
709540975
Labeler code
70954
Product ID
70954-975_a1fa7066-8ab4-47e3-a701-6c5170700d11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sacubitril and Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA213676
Marketing category
ANDA
Marketing start
2025-07-24
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
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
70954-975-20Sacubitril and Valsartan60 in 1 BOTTLETABLET, FILM COATED602
70954-975-30Sacubitril and Valsartan180 in 1 BOTTLETABLET, FILM COATED1802
70954-975-50Sacubitril and Valsartan1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-975-20EA - Each70954-97539271f99-0cd3-4cb7-984a-8401bfc1071412025-08-11
70954-975-30EA - Each70954-9751aae1a89-0f08-4966-be90-2a0287e7e37d12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSNa1fa7066-8ab4-47e3-a701-6c5170700d112
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSNa1fa7066-8ab4-47e3-a701-6c5170700d112
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSNa1fa7066-8ab4-47e3-a701-6c5170700d112
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCDa1fa7066-8ab4-47e3-a701-6c5170700d112
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCDa1fa7066-8ab4-47e3-a701-6c5170700d112
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCDa1fa7066-8ab4-47e3-a701-6c5170700d112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70954-975-207095409752060 TABLET, FILM COATED in 1 BOTTLE (70954-975-20) 2025-07-24NoNoCurrent
70954-975-3070954097530180 TABLET, FILM COATED in 1 BOTTLE (70954-975-30) 2025-07-24NoNoCurrent
70954-975-50709540975501000 TABLET, FILM COATED in 1 BOTTLE (70954-975-50)2026-05-270Current