FDA.reportPublic FDA data

Irbesartan

Product NDC
50268-441
11-digit product format
502680441
Labeler code
50268
Product ID
50268-441_3c1c8771-3bbc-7b5a-e063-6394a90a192c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA202910
Marketing category
ANDA
Marketing start
2023-08-08
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
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
50268-441-11Irbesartan1 in 1 BLISTER PACKTABLET19
50268-441-15Irbesartan50 in 1 BOX, UNIT-DOSETABLET509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-441-11EA - Each50268-4417dd41205-fe54-4d2a-a580-89e98642ac5a12015-12-02
50268-441-15EA - Each50268-441e7444a5c-bab5-4ad8-a7c1-bd6cd4f3c14f12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IRBESARTANACTIVE INGREDIENTJ0E2756Z7NIRBESARTAN TABLET [AVPAK]1
IRBESARTANACTIVE MOIETYJ0E2756Z7NIRBESARTAN TABLET [AVPAK]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LIRBESARTAN TABLET [AVPAK]1
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LIRBESARTAN TABLET [AVPAK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIRBESARTAN TABLET [AVPAK]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IRBESARTAN TABLET [AVPAK]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XIRBESARTAN TABLET [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-441IRBESARTAN TABLET [AVPAK]8Current NDC, Legacy NDC, 2 package rows20250112_61b60f94-35e6-b90b-08ce-fbb2fe011f34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSN61b60f94-35e6-b90b-08ce-fbb2fe011f349
200096irbesartan 300 MG Oral TabletPSN61b60f94-35e6-b90b-08ce-fbb2fe011f349
200094irbesartan 75 MG Oral TabletPSN61b60f94-35e6-b90b-08ce-fbb2fe011f349
200095irbesartan 150 MG Oral TabletSCD61b60f94-35e6-b90b-08ce-fbb2fe011f349
200096irbesartan 300 MG Oral TabletSCD61b60f94-35e6-b90b-08ce-fbb2fe011f349
200094irbesartan 75 MG Oral TabletSCD61b60f94-35e6-b90b-08ce-fbb2fe011f349

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-441-11502680441111 in 1 BLISTER PACKHistorical
50268-441-155026804411550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-441-15) / 1 TABLET in 1 BLISTER PACK (50268-441-11) 50 blister pack2023-08-08NoNoCurrent