FDA.reportPublic FDA data

Irbesartan

Product NDC
50090-1284
11-digit product format
500901284
Labeler code
50090
Product ID
50090-1284_6fdd10d2-4cb2-4631-bc45-744660ae5bb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202910
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, 200096

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1284-0Irbesartan30 in 1 BOTTLETABLET3023
50090-1284-1Irbesartan90 in 1 BOTTLE, PLASTICTABLET9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1284-0EA - Each50090-128435496f07-68d7-4bca-aba8-f6b8e2cdc91112018-11-06
50090-1284-1EA - Each50090-1284fba56d97-275b-4b0b-b458-17288f83d52212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1284IRBESARTAN TABLET IRBESARTAN TABLET [A-S MEDICATION SOLUTIONS]23Current NDC, Legacy NDC, 2 package rows20231222_868bd0a7-38ff-4722-8063-a697af3be527.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSN868bd0a7-38ff-4722-8063-a697af3be52723
200096irbesartan 300 MG Oral TabletPSN868bd0a7-38ff-4722-8063-a697af3be52723
200095irbesartan 150 MG Oral TabletSCD868bd0a7-38ff-4722-8063-a697af3be52723
200096irbesartan 300 MG Oral TabletSCD868bd0a7-38ff-4722-8063-a697af3be52723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1284-05009012840030 TABLET in 1 BOTTLE (50090-1284-0) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-1284-15009012840190 TABLET in 1 BOTTLE, PLASTIC (50090-1284-1) 90 tablet2014-11-280000-00-00NoNoCurrent