FDA.reportPublic FDA data

Irbesartan

Product NDC
71335-1263
11-digit product format
713351263
Labeler code
71335
Product ID
71335-1263_d7a9893c-a353-4aa3-8ca2-78f4c3ab96c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202254
Marketing category
ANDA
Marketing start
2012-09-27
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRBESARTAN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ0E2756Z7N
Rxcui200095

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
71335-1263-12025-11-21C16284748780-11030e365-2532-111a-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
71335-1263-22025-11-21C16284748780-11030e365-2532-111a-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
71335-1263-32025-11-21C16284748780-11030e365-2532-111a-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
71335-1263-12024-01-30C16284748780-11030e365-2532-111a-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
71335-1263-22024-01-30C16284748780-11030e365-2532-111a-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
71335-1263-32024-01-30C16284748780-11030e365-2532-111a-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
71335-1263-1Irbesartan30 in 1 BOTTLETABLET303
71335-1263-2Irbesartan60 in 1 BOTTLETABLET603
71335-1263-3Irbesartan90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1263IRBESARTAN TABLET [BRYANT RANCH PREPACK]2Current NDC, Legacy NDC, 3 package rows20220204_bc07bbf5-b1c6-4854-b6af-e06520c20728.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSNbc07bbf5-b1c6-4854-b6af-e06520c207283
200095irbesartan 150 MG Oral TabletSCDbc07bbf5-b1c6-4854-b6af-e06520c207283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1263-17133512630130 TABLET in 1 BOTTLE (71335-1263-1) 30 tablet2019-10-290000-00-00NoNoCurrent
71335-1263-27133512630260 TABLET in 1 BOTTLE (71335-1263-2) 60 tablet2021-12-280000-00-00NoNoCurrent
71335-1263-37133512630390 TABLET in 1 BOTTLE (71335-1263-3) 90 tablet2019-07-020000-00-00NoNoCurrent