FDA.reportPublic FDA data

Irbesartan

Product NDC
71335-1826
11-digit product format
713351826
Labeler code
71335
Product ID
71335-1826_2626c411-fe85-4478-b07a-1f1e412b0ab4
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1826-1Irbesartan30 in 1 BOTTLETABLET30101
71335-1826-2Irbesartan90 in 1 BOTTLETABLET90101
71335-1826-3Irbesartan28 in 1 BOTTLETABLET28101
71335-1826-4Irbesartan60 in 1 BOTTLETABLET60101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1826IRBESARTAN TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 4 package rows20231128_21dd9a41-93c7-470c-94ed-f4c24e3d5633.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200096irbesartan 300 MG Oral TabletPSN21dd9a41-93c7-470c-94ed-f4c24e3d5633101
200096irbesartan 300 MG Oral TabletSCD21dd9a41-93c7-470c-94ed-f4c24e3d5633101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1826-17133518260130 TABLET in 1 BOTTLE (71335-1826-1) 30 tablet2021-12-210000-00-00NoNoCurrent
71335-1826-27133518260290 TABLET in 1 BOTTLE (71335-1826-2) 90 tablet2021-12-210000-00-00NoNoCurrent
71335-1826-37133518260328 TABLET in 1 BOTTLE (71335-1826-3) 28 tablet2021-12-210000-00-00NoNoCurrent
71335-1826-47133518260460 TABLET in 1 BOTTLE (71335-1826-4) 60 tablet2021-12-210000-00-00NoNoCurrent