FDA.reportPublic FDA data

Irbesartan

Product NDC
50090-2978
11-digit product format
500902978
Labeler code
50090
Product ID
50090-2978_5356b88b-6a90-479c-bc73-8aec58cb3e9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203071
Marketing category
ANDA
Marketing start
2016-06-13
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
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
IRBESARTAN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ0E2756Z7N
Rxcui200096

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
50090-2978-02025-08-08C16284748780-1f386c64a-498e-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
50090-2978-02023-01-30C16284748780-1f386c64a-498e-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
50090-2978-0Irbesartan30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2978-0EA - Each50090-2978c57f5145-1117-49e7-ad9c-59e0fa8802d512019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2978IRBESARTAN TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20191010_70a25c6d-23ce-488c-9ef8-62b3b99e5052.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200096irbesartan 300 MG Oral TabletPSN70a25c6d-23ce-488c-9ef8-62b3b99e50526
200096irbesartan 300 MG Oral TabletSCD70a25c6d-23ce-488c-9ef8-62b3b99e50526

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2978-05009029780030 TABLET in 1 BOTTLE (50090-2978-0) 30 tablet2017-04-200000-00-00NoNoCurrent