FDA.reportPublic FDA data

IRBESARTAN

Product NDC
50090-4519
11-digit product format
500904519
Labeler code
50090
Product ID
50090-4519_1ae0032e-59fe-4c9d-8a39-0fb7ff842a08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IRBESARTAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206194
Marketing category
ANDA
Marketing start
2017-04-15
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
50090-4519-02023-01-30C16284748780-1f386c64a-2958-0266-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
50090-4519-12023-01-30C16284748780-1f386c64a-2958-0266-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
50090-4519-0IRBESARTAN30 in 1 BOTTLETABLET, FILM COATED302
50090-4519-1IRBESARTAN90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4519-0EA - Each50090-4519362a2265-0e5d-4f07-b5da-16cda04b8a7212022-07-06
50090-4519-1EA - Each50090-45193d9e0cac-b349-4982-9e41-49354b804f9f12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4519IRBESARTAN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20191003_a3a3c7d3-fd55-45b6-9f5c-a9de0b2d8648.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200096irbesartan 300 MG Oral TabletPSNa3a3c7d3-fd55-45b6-9f5c-a9de0b2d86482
200096irbesartan 300 MG Oral TabletSCDa3a3c7d3-fd55-45b6-9f5c-a9de0b2d86482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4519-05009045190030 TABLET, FILM COATED in 1 BOTTLE (50090-4519-0) 2019-09-120000-00-00NoNoCurrent
50090-4519-15009045190190 TABLET, FILM COATED in 1 BOTTLE (50090-4519-1) 2019-09-120000-00-00NoNoCurrent