FDA.reportPublic FDA data

Sacubitril and Valsartan

Product NDC
72205-282
11-digit product format
722050282
Labeler code
72205
Product ID
72205-282_84f16efa-73b8-419b-adb9-18c18c31a11f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sacubitril and Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA213748
Marketing category
ANDA
Marketing start
2025-07-16
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
72205-282-18Sacubitril and Valsartan180 in 1 BOTTLETABLET, FILM COATED1802
72205-282-60Sacubitril and Valsartan60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-282-18EA - Each72205-2828aada810-020c-41e3-83b0-d2ddfde4a17712025-08-11
72205-282-60EA - Each72205-28278736971-1f7a-47b9-8f87-2b1ed9ac8f6b12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-282SACUBITRIL AND VALSARTAN TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 2 package rows20250117_44db8114-622e-41f6-96a1-447d47b0267c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN2c39c326-34a2-b7f4-e063-6294a90a67324
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN2c39c326-34a2-b7f4-e063-6294a90a67324
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN2c39c326-34a2-b7f4-e063-6294a90a67324
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD2c39c326-34a2-b7f4-e063-6294a90a67324
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD2c39c326-34a2-b7f4-e063-6294a90a67324
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD2c39c326-34a2-b7f4-e063-6294a90a67324
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN4114a976-2e58-8437-e063-6394a90af2982
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN44db8114-622e-41f6-96a1-447d47b0267c2
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN4114a976-2e58-8437-e063-6394a90af2982
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN44db8114-622e-41f6-96a1-447d47b0267c2
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN4114a976-2e58-8437-e063-6394a90af2982
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN44db8114-622e-41f6-96a1-447d47b0267c2
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD4114a976-2e58-8437-e063-6394a90af2982
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD44db8114-622e-41f6-96a1-447d47b0267c2
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD4114a976-2e58-8437-e063-6394a90af2982
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD44db8114-622e-41f6-96a1-447d47b0267c2
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD4114a976-2e58-8437-e063-6394a90af2982
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD44db8114-622e-41f6-96a1-447d47b0267c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-282-1872205028218180 TABLET, FILM COATED in 1 BOTTLE (72205-282-18) 2025-07-22NoNoCurrent
72205-282-607220502826060 TABLET, FILM COATED in 1 BOTTLE (72205-282-60) 2025-07-22NoNoCurrent