FDA.reportPublic FDA data

IRBESARTAN

Product NDC
50090-3431
11-digit product format
500903431
Labeler code
50090
Product ID
50090-3431_19fd3d89-3d07-4b91-aba7-4c2d67b4fc0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IRBESARTAN
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091236
Marketing category
ANDA
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
IRBESARTAN
Active strength
300 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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
50090-3431-12023-01-30C16284748780-1f386c64a-19f5-0266-e053-dadaa90a7c1aThese 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
50090-3431-22023-01-30C16284748780-1f386c64a-19f5-0266-e053-dadaa90a7c1aThese 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
50090-3431-1IRBESARTAN90 in 1 BOTTLETABLET905
50090-3431-2IRBESARTAN90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3431-1EA - Each50090-34315ca5e7d3-af21-4d75-baf2-739837b607ca12019-05-02
50090-3431-2EA - Each50090-3431ce7aa532-275c-475c-ae18-c90d73d6590212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3431IRBESARTAN TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20190430_19db26af-5de5-4280-b743-194c61b1cb01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200096irbesartan 300 MG Oral TabletPSN19db26af-5de5-4280-b743-194c61b1cb015
200096irbesartan 300 MG Oral TabletSCD19db26af-5de5-4280-b743-194c61b1cb015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3431-15009034310190 TABLET in 1 BOTTLE (50090-3431-1) 90 tablet2018-04-260000-00-00NoNoCurrent
50090-3431-25009034310290 TABLET in 1 BOTTLE, PLASTIC (50090-3431-2) 90 tablet2016-07-010000-00-00NoNoCurrent