Irbesartan

Product NDC
50268-440
11-digit product format
502680440
Labeler code
50268
Product ID
50268-440_7d779f01-0498-34e9-e053-2a91aa0a749c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA202910
Marketing category
ANDA
Marketing start
2015-10-27
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50268-440DDiscontinued by firm2026-08-11
excluded packagepackage50268-44050268-440-15DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50268-440-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50268-440-15f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202910-001IRBESARTANIRBESARTAN75MGTABLET / ORALAB2012-09-27
A202910-002IRBESARTANIRBESARTAN150MGTABLET / ORALAB2012-09-27
A202910-003IRBESARTANIRBESARTAN300MGTABLET / ORALAB2012-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202910-001AB
A202910-002AB
A202910-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202910-002IRBESARTAN150MGTABLET / ORALAB2012-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202910-003IRBESARTAN300MGTABLET / ORALAB2012-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202910-001IRBESARTAN75MGTABLET / ORALAB2012-09-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202910-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202910-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202910-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202910-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202910-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202910-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202910-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202910-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202910-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202910-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202910-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202910-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202910-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202910-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202910-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202910-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202910-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202910-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202910-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202910-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202910-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202910-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202910-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202910-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202910-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202910-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202910-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202910-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202910-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202910-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202910-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202910-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202910-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202910-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202910-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202910-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202910-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202910-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202910-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202910-001AB18072bd15b7f6…

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
50268-440-11Irbesartan1 in 1 BLISTER PACKTABLET19
50268-440-15Irbesartan50 in 1 BOX, UNIT-DOSETABLET509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-440-11EA - Each50268-44031130f72-82d0-4a2b-8e16-195b8457d91312015-12-02
50268-440-15EA - Each50268-440828cb614-718f-4e08-9935-c40c3a511eac12015-12-02

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
50268-440IRBESARTAN TABLET [AVPAK]8Legacy NDC, 2 package rows20250112_61b60f94-35e6-b90b-08ce-fbb2fe011f34.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IrbesartanIRBESARTANREMEDYREPACK INC.5b259fdd-ca4c-49c9-a50d-86066f5b07462026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
IrbesartanIRBESARTANBryant Ranch Prepack7e0ddb7b-80c5-47ab-afee-c74bb735e8292026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
IrbesartanIRBESARTANBryant Ranch Prepack21dd9a41-93c7-470c-94ed-f4c24e3d56332026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
IrbesartanIRBESARTANPreferred Pharmaceuticals Inc.197871da-e0c5-49a9-8dd0-34a8c2685c6b2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
IrbesartanIRBESARTANREMEDYREPACK INC.0c1fc197-c2d9-453c-b79f-b53de89c188b2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
IrbesartanIRBESARTANREMEDYREPACK INC.bb58acb0-2dc0-45ee-86bb-b405b1b75cff2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
IrbesartanIRBESARTANCamber Pharmaceuticals, Inc.33416f1e-adee-4a45-b6fe-1fc39044e3072026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
IrbesartanIRBESARTANAvPAK61b60f94-35e6-b90b-08ce-fbb2fe011f342025-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
ndc (product): 50268-440
IRBESARTANIRBESARTANdirect rxbfdf76ae-fedf-630c-e053-2995a90a98682025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
IrbesartanIRBESARTANQuality Care Products, LLC9b8581c1-d052-4fe2-a9fc-cf7adf0f90612024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
IrbesartanIRBESARTANBryant Ranch Prepack5c125c2a-a709-4cf1-b2d5-6e1d24a773772024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
IrbesartanIRBESARTANA-S Medication Solutions9644fa38-dd28-4888-9d55-80967c4fc8d72023-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
IrbesartanIRBESARTANA-S Medication Solutions868bd0a7-38ff-4722-8063-a697af3be5272023-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910
IrbesartanIRBESARTANProficient Rx LP950e33da-5e77-40df-b73b-dd084b36a8042022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202910
application number: ANDA202910

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 formatDescriptionStatus
50268-440-11502680440111 in 1 BLISTER PACKHistorical
50268-440-155026804401550 in 1 BOX, UNIT-DOSEHistorical