FDA.reportPublic FDA data

Irbesartan

Product NDC
50090-5055
11-digit product format
500905055
Labeler code
50090
Product ID
50090-5055_0c10c737-06da-44cf-a416-aec10925677d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
irbesartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA020757
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-09-30
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
2022-12-31
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
50090-5055-02023-01-30C16284748780-1f386c649-b299-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Irbesartan safely and effectively. See full prescribing information for Irbesartan. Irbesartan tablets, for oral use Initial U.S. Approval: 1997
50090-5055-12023-01-30C16284748780-1f386c649-b299-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Irbesartan safely and effectively. See full prescribing information for Irbesartan. Irbesartan tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5055-0Irbesartan30 in 1 BOTTLETABLET, FILM COATED306
50090-5055-1Irbesartan90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5055-1EA - Each50090-50559cdb1ef9-49c5-4fda-84bb-ce20e36632a612022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5055IRBESARTAN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20210615_07a6a82f-6a28-4784-8fbc-6f356ecdcdd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200096irbesartan 300 MG Oral TabletPSN07a6a82f-6a28-4784-8fbc-6f356ecdcdd16
200096irbesartan 300 MG Oral TabletSCD07a6a82f-6a28-4784-8fbc-6f356ecdcdd16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5055-05009050550030 TABLET, FILM COATED in 1 BOTTLE (50090-5055-0) 2020-05-210000-00-00NoNoCurrent
50090-5055-15009050550190 TABLET, FILM COATED in 1 BOTTLE (50090-5055-1) 2020-05-210000-00-00NoNoCurrent