FDA.reportPublic FDA data

sacubitril and valsartan

Product NDC
13668-635
11-digit product format
136680635
Labeler code
13668
Product ID
13668-635_d75a5a57-6ab2-4aa3-abc5-de648ac84e65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sacubitril and valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA213604
Marketing category
ANDA
Marketing start
2025-07-16
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
13668-635-05sacubitril and valsartan500 in 1 BOTTLETABLET50012
13668-635-33sacubitril and valsartan180 in 1 BOTTLETABLET18012
13668-635-60sacubitril and valsartan60 in 1 BOTTLETABLET6012
13668-635-71sacubitril and valsartan10 in 1 BLISTER PACKTABLET1012
13668-635-74sacubitril and valsartan100 in 1 CARTONTABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-635-33EA - Each13668-635aa7237e3-a0ad-4282-b38b-d397f4d96cd312025-08-11
13668-635-60EA - Each13668-635ca0b47b8-718e-4a7b-ac62-70d7eb9d41df12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-635SACUBITRIL AND VALSARTAN TABLET [TORRENT PHARMACEUTICALS LIMITED]10Current NDC, 5 package rows20241211_59b7a07a-96ee-44b1-8dae-2b42169aa2c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN59b7a07a-96ee-44b1-8dae-2b42169aa2c512
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN59b7a07a-96ee-44b1-8dae-2b42169aa2c512
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN59b7a07a-96ee-44b1-8dae-2b42169aa2c512
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD59b7a07a-96ee-44b1-8dae-2b42169aa2c512
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD59b7a07a-96ee-44b1-8dae-2b42169aa2c512
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD59b7a07a-96ee-44b1-8dae-2b42169aa2c512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-635-0513668063505500 TABLET in 1 BOTTLE (13668-635-05) 500 tablet2025-07-16NoNoCurrent
13668-635-3313668063533180 TABLET in 1 BOTTLE (13668-635-33) 180 tablet2025-07-16NoNoCurrent
13668-635-601366806356060 TABLET in 1 BOTTLE (13668-635-60) 60 tablet2025-07-16NoNoCurrent
13668-635-711366806357110 in 1 BLISTER PACKHistorical
13668-635-7413668063574100 BLISTER PACK in 1 CARTON (13668-635-74) / 10 TABLET in 1 BLISTER PACK (13668-635-71) 100 blister pack2025-07-16NoNoCurrent