Irbesartan

Product NDC
72162-2354
11-digit product format
721622354
Labeler code
72162
Product ID
72162-2354_b0f670f2-c795-4b5d-9863-907b40b1e0f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
72162-2354-3Irbesartan30 in 1 BOTTLETABLET30102
72162-2354-9Irbesartan90 in 1 BOTTLETABLET90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2354-3EA - Each72162-2354b7f1ffcd-9160-4542-8b66-7ee7f292a8d012024-08-12
72162-2354-9EA - Each72162-2354b669de98-51c6-447c-b33f-42a9feb3559512024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2354IRBESARTAN (IRBESARTAN) TABLET [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20250226_5c125c2a-a709-4cf1-b2d5-6e1d24a77377.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSN5c125c2a-a709-4cf1-b2d5-6e1d24a77377102
200095irbesartan 150 MG Oral TabletSCD5c125c2a-a709-4cf1-b2d5-6e1d24a77377102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2354-37216223540330 TABLET in 1 BOTTLE (72162-2354-3) 30 tablet2024-06-28NoNoHistorical
72162-2354-97216223540990 TABLET in 1 BOTTLE (72162-2354-9) 90 tablet2024-06-28NoNoHistorical