FDA.reportPublic FDA data

sacubitril and valsartan

Product NDC
46708-558
11-digit product format
467080558
Labeler code
46708
Product ID
46708-558_e4716fc9-5f73-4303-8a4e-e8f9129b6e2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sacubitril and valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA213682
Marketing category
ANDA
Marketing start
2024-11-04
Substance
SACUBITRIL; VALSARTAN
Active strength
97; 103 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
SACUBITRIL97 mg/1
VALSARTAN103 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
46708-558-10sacubitril and valsartan10 in 1 BLISTER PACKTABLET, FILM COATED101
46708-558-10sacubitril and valsartan100 in 1 CARTONTABLET, FILM COATED1001
46708-558-45sacubitril and valsartan180 in 1 BOTTLETABLET, FILM COATED1801
46708-558-60sacubitril and valsartan60 in 1 BOTTLETABLET, FILM COATED601
46708-558-91sacubitril and valsartan1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-558SACUBITRIL AND VALSARTAN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 5 package rows20241105_e4716fc9-5f73-4303-8a4e-e8f9129b6e2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSNe4716fc9-5f73-4303-8a4e-e8f9129b6e2d1
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSNe4716fc9-5f73-4303-8a4e-e8f9129b6e2d1
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSNe4716fc9-5f73-4303-8a4e-e8f9129b6e2d1
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCDe4716fc9-5f73-4303-8a4e-e8f9129b6e2d1
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCDe4716fc9-5f73-4303-8a4e-e8f9129b6e2d1
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCDe4716fc9-5f73-4303-8a4e-e8f9129b6e2d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-558-1046708055810100 BLISTER PACK in 1 CARTON (46708-558-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2024-11-04NoNoCurrent
46708-558-4546708055845180 TABLET, FILM COATED in 1 BOTTLE (46708-558-45) 2024-11-04NoNoCurrent
46708-558-604670805586060 TABLET, FILM COATED in 1 BOTTLE (46708-558-60) 2024-11-04NoNoCurrent
46708-558-91467080558911000 TABLET, FILM COATED in 1 BOTTLE (46708-558-91) 2024-11-04NoNoCurrent