IRBESARTAN

Product NDC
72189-270
11-digit product format
721890270
Labeler code
72189
Product ID
72189-270_2c290c08-d35e-21b4-e063-6394a90a73b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IRBESARTAN
Dosage form
TABLET
Route
ORAL
Labeler
direct rx
Application
ANDA202910
Marketing category
ANDA
Marketing start
2021-09-16
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
Rxcui200094, 200095, 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
72189-270-90IRBESARTAN90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-270IRBESARTAN TABLET [DIRECT RX]5Current NDC, Legacy NDC, 1 package rows20250121_bfdf76ae-fedf-630c-e053-2995a90a9868.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSNbfdf76ae-fedf-630c-e053-2995a90a98685
200096irbesartan 300 MG Oral TabletPSNbfdf76ae-fedf-630c-e053-2995a90a98685
200094irbesartan 75 MG Oral TabletPSNbfdf76ae-fedf-630c-e053-2995a90a98685
200095irbesartan 150 MG Oral TabletSCDbfdf76ae-fedf-630c-e053-2995a90a98685
200096irbesartan 300 MG Oral TabletSCDbfdf76ae-fedf-630c-e053-2995a90a98685
200094irbesartan 75 MG Oral TabletSCDbfdf76ae-fedf-630c-e053-2995a90a98685

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-270-907218902709090 TABLET in 1 BOTTLE (72189-270-90) 90 tablet2021-09-160000-00-00NoNoCurrent