FDA.reportPublic FDA data

valsartan

Product NDC
59746-363
11-digit product format
597460363
Labeler code
59746
Product ID
59746-363_9c828bee-09d3-4021-99e7-e5fd3e83741c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA203536
Marketing category
ANDA
Marketing start
2015-01-05
Substance
VALSARTAN
Active strength
320 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
VALSARTAN320 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59746-363-302023-02-24C16284748780-1f386c649-ba42-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996
59746-363-322023-02-24C16284748780-1f386c649-ba42-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996
59746-363-672023-02-24C16284748780-1f386c649-ba42-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996
59746-363-902023-02-24C16284748780-1f386c649-ba42-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996
59746-363-302023-01-30C16284748780-1f386c649-ba42-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996
59746-363-322023-01-30C16284748780-1f386c649-ba42-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996
59746-363-672023-01-30C16284748780-1f386c649-ba42-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996
59746-363-902023-01-30C16284748780-1f386c649-ba42-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-363-30valsartan30 in 1 BOTTLETABLET309
59746-363-32valsartan10 in 1 BLISTER PACKTABLET109
59746-363-32valsartan3 in 1 CARTONTABLET39
59746-363-67valsartan400 in 1 BOTTLETABLET4009
59746-363-90valsartan90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-363-90EA - Each59746-36388996d70-f848-4a4b-9a9b-0ace6a4da53c12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKVALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UVALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1
CrospovidoneINACTIVE INGREDIENT68401960MKVALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTVALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOVALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AVALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPVALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-363VALSARTAN TABLET [JUBILANT CADISTA PHARMACUTICALS INC.]9Current NDC, Legacy NDC, 5 package rows20250305_9402b022-5809-4251-dfef-54f6ef5723fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN9402b022-5809-4251-dfef-54f6ef5723fe9
349200valsartan 320 MG Oral TabletPSN9402b022-5809-4251-dfef-54f6ef5723fe9
349483valsartan 40 MG Oral TabletPSN9402b022-5809-4251-dfef-54f6ef5723fe9
349199valsartan 80 MG Oral TabletPSN9402b022-5809-4251-dfef-54f6ef5723fe9
349201valsartan 160 MG Oral TabletSCD9402b022-5809-4251-dfef-54f6ef5723fe9
349200valsartan 320 MG Oral TabletSCD9402b022-5809-4251-dfef-54f6ef5723fe9
349483valsartan 40 MG Oral TabletSCD9402b022-5809-4251-dfef-54f6ef5723fe9
349199valsartan 80 MG Oral TabletSCD9402b022-5809-4251-dfef-54f6ef5723fe9
349200valsartan 320 MG Oral TabletPSN80987771-ccb4-4a9f-a395-0af4c2621e0a5
349200valsartan 320 MG Oral TabletSCD80987771-ccb4-4a9f-a395-0af4c2621e0a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-363-305974603633030 TABLET in 1 BOTTLE (59746-363-30) 30 tablet2015-01-050000-00-00NoNoCurrent
59746-363-32597460363323 BLISTER PACK in 1 CARTON (59746-363-32) / 10 TABLET in 1 BLISTER PACK3 blister pack2015-01-050000-00-00NoNoCurrent
59746-363-6759746036367400 TABLET in 1 BOTTLE (59746-363-67) 400 tablet2015-01-050000-00-00NoNoCurrent
59746-363-905974603639090 TABLET in 1 BOTTLE (59746-363-90) 90 tablet2015-01-050000-00-00NoNoCurrent