FDA.reportPublic FDA data

Valsartan

Product NDC
71335-1337
11-digit product format
713351337
Labeler code
71335
Product ID
71335-1337_7cb9f284-8175-4679-b846-145dc604e2c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205536
Marketing category
ANDA
Marketing start
2019-03-14
Marketing end
0000-00-00
Substance
VALSARTAN
Active strength
40 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

Additional Listing Data#

Finished product
Yes
Brand name base
Valsartan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80M03YXJ7I

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
71335-1337-12024-01-30C16284748780-11030e365-0887-111a-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
71335-1337-12024-01-30C16284748780-11030e365-0887-111a-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
71335-1337-1Valsartan30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1337VALSARTAN TABLET, FILM COATED [BRYANT RANCH PREPACK]2Legacy NDC, 1 package rows20220204_7cb9f284-8175-4679-b846-145dc604e2c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349483valsartan 40 MG Oral TabletPSN7cb9f284-8175-4679-b846-145dc604e2c02
349483valsartan 40 MG Oral TabletSCD7cb9f284-8175-4679-b846-145dc604e2c02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1337-17133513370130 TABLET, FILM COATED in 1 BOTTLE (71335-1337-1) 2019-09-120000-00-00NoNoCurrent
71335-1337-27133513370290 TABLET, FILM COATED in 1 BOTTLE (71335-1337-2)2026-06-120Current