Irbesartan

Product NDC
71335-2745
11-digit product format
713352745
Labeler code
71335
Product ID
71335-2745_7bb4b143-ca51-4197-826d-4da0cbb6b953
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203071
Marketing category
ANDA
Marketing start
2016-06-13
Substance
IRBESARTAN
Active strength
75 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
IRBESARTAN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ0E2756Z7N
Rxcui200094

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
71335-2745-1Irbesartan30 in 1 BOTTLETABLET301
71335-2745-2Irbesartan90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200094irbesartan 75 MG Oral TabletPSN14d85774-2d74-4300-b4bb-c2836db4d5bd1
200094irbesartan 75 MG Oral TabletSCD14d85774-2d74-4300-b4bb-c2836db4d5bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2745-17133527450130 TABLET in 1 BOTTLE (71335-2745-1) 30 tablet2025-10-02NoNoHistorical
71335-2745-27133527450290 TABLET in 1 BOTTLE (71335-2745-2) 90 tablet2025-10-02NoNoHistorical