FDA.reportPublic FDA data

IRBESARTAN

Product NDC
71335-0423
11-digit product format
713350423
Labeler code
71335
Product ID
71335-0423_01c9caf2-97f7-4d48-8599-51fc54047046
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IRBESARTAN
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091236
Marketing category
ANDA
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
IRBESARTAN
Active strength
150 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
34942a29-de4f-d63c-7755-ba18fe1411a0Product name620180619
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0423-12024-01-30C16284748780-11030e365-5b91-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997
71335-0423-22024-01-30C16284748780-11030e365-5b91-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997
71335-0423-32024-01-30C16284748780-11030e365-5b91-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0423-1IRBESARTAN30 in 1 BOTTLETABLET306
71335-0423-2IRBESARTAN60 in 1 BOTTLETABLET606
71335-0423-3IRBESARTAN90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0423-1EA - Each71335-0423097e3bd3-99a4-4cbd-9ed5-2d58e777a23e12018-03-08
71335-0423-2EA - Each71335-04237238f51b-ff89-40ad-ac66-9df13744fc5f12018-03-08
71335-0423-3EA - Each71335-04239a4c725d-1c42-41a1-892c-6f396fe5a06812018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0423IRBESARTAN TABLET [BRYANT RANCH PREPACK]6Legacy NDC, 3 package rows20220129_01c9caf2-97f7-4d48-8599-51fc54047046.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSN01c9caf2-97f7-4d48-8599-51fc540470466
200095irbesartan 150 MG Oral TabletSCD01c9caf2-97f7-4d48-8599-51fc540470466

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0423-17133504230130 TABLET in 1 BOTTLE (71335-0423-1) 30 tablet2019-02-140000-00-00NoNoCurrent
71335-0423-27133504230260 TABLET in 1 BOTTLE (71335-0423-2) 60 tablet2021-12-270000-00-00NoNoCurrent
71335-0423-37133504230390 TABLET in 1 BOTTLE (71335-0423-3) 90 tablet2021-12-270000-00-00NoNoCurrent