Valsartan

Product NDC
76483-024
11-digit product format
764830024
Labeler code
76483
Product ID
76483-024_9f718442-a70e-4f30-8a1e-456392400ec0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET
Route
ORAL
Labeler
SQUARE PHARMACEUTICALS LIMITED
Application
ANDA205347
Marketing category
ANDA
Marketing start
2022-07-15
Substance
VALSARTAN
Active strength
160 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valsartan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80M03YXJ7I
Rxcui349199, 349200, 349201, 349483

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
76483-024-00Valsartan30 in 1 BOTTLETABLET3010
76483-024-03Valsartan90 in 1 BOTTLETABLET9010
76483-024-04Valsartan100 in 1 BOTTLETABLET10010
76483-024-05Valsartan500 in 1 BOTTLETABLET50010
76483-024-06Valsartan1000 in 1 BOTTLETABLET100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76483-024VALSARTAN TABLET [SQUARE PHARMACEUTICALS LIMITED]10Current NDC, Legacy NDC, 5 package rows20230706_5ee97546-2a7c-40fa-9e05-b7993a72dfbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN5ee97546-2a7c-40fa-9e05-b7993a72dfbf10
349200valsartan 320 MG Oral TabletPSN5ee97546-2a7c-40fa-9e05-b7993a72dfbf10
349483valsartan 40 MG Oral TabletPSN5ee97546-2a7c-40fa-9e05-b7993a72dfbf10
349199valsartan 80 MG Oral TabletPSN5ee97546-2a7c-40fa-9e05-b7993a72dfbf10
349201valsartan 160 MG Oral TabletSCD5ee97546-2a7c-40fa-9e05-b7993a72dfbf10
349200valsartan 320 MG Oral TabletSCD5ee97546-2a7c-40fa-9e05-b7993a72dfbf10
349483valsartan 40 MG Oral TabletSCD5ee97546-2a7c-40fa-9e05-b7993a72dfbf10
349199valsartan 80 MG Oral TabletSCD5ee97546-2a7c-40fa-9e05-b7993a72dfbf10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76483-024-007648300240030 TABLET in 1 BOTTLE (76483-024-00) 30 tablet2022-07-150000-00-00NoNoCurrent
76483-024-037648300240390 TABLET in 1 BOTTLE (76483-024-03) 90 tablet2022-07-150000-00-00NoNoCurrent
76483-024-0476483002404100 TABLET in 1 BOTTLE (76483-024-04) 100 tablet2022-07-150000-00-00NoNoCurrent
76483-024-0576483002405500 TABLET in 1 BOTTLE (76483-024-05) 500 tablet2022-07-150000-00-00NoNoCurrent
76483-024-06764830024061000 TABLET in 1 BOTTLE (76483-024-06) 1000 tablet2022-07-150000-00-00NoNoCurrent