FDA.reportPublic FDA data

Valsartan

Product NDC
71335-1561
11-digit product format
713351561
Labeler code
71335
Product ID
71335-1561_098258be-67f8-4ff2-ac89-1638fec335bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091367
Marketing category
ANDA
Marketing start
2016-05-20
Marketing end
0000-00-00
Substance
VALSARTAN
Active strength
80 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
71335-1561-12024-01-30C16284748780-11030e365-2cb0-111a-e063-dadaa90a10e2These 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
71335-1561-22024-01-30C16284748780-11030e365-2cb0-111a-e063-dadaa90a10e2These 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
71335-1561-32024-01-30C16284748780-11030e365-2cb0-111a-e063-dadaa90a10e2These 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
71335-1561-42024-01-30C16284748780-11030e365-2cb0-111a-e063-dadaa90a10e2These 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
71335-1561-1Valsartan30 in 1 BOTTLETABLET30100
71335-1561-2Valsartan90 in 1 BOTTLETABLET90100
71335-1561-3Valsartan60 in 1 BOTTLETABLET60100
71335-1561-4Valsartan28 in 1 BOTTLETABLET28100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1561VALSARTAN TABLET [BRYANT RANCH PREPACK]100Legacy NDC, 4 package rows20220211_9288b57c-d9e5-4274-83ea-1d3095cbc4f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349199valsartan 80 MG Oral TabletPSN9288b57c-d9e5-4274-83ea-1d3095cbc4f2100
349199valsartan 80 MG Oral TabletSCD9288b57c-d9e5-4274-83ea-1d3095cbc4f2100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1561-17133515610130 TABLET in 1 BOTTLE (71335-1561-1) 30 tablet2022-02-100000-00-00NoNoCurrent
71335-1561-27133515610290 TABLET in 1 BOTTLE (71335-1561-2) 90 tablet2022-02-100000-00-00NoNoCurrent
71335-1561-37133515610360 TABLET in 1 BOTTLE (71335-1561-3) 60 tablet2022-02-100000-00-00NoNoCurrent
71335-1561-47133515610428 TABLET in 1 BOTTLE (71335-1561-4) 28 tablet2022-02-100000-00-00NoNoCurrent