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

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202910-001	IRBESARTAN	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27
A202910-002	IRBESARTAN	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27
A202910-003	IRBESARTAN	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202910-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202910-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202910-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202910-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202910-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202910-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202910-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202910-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202910-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202910-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202910-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202910-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202910-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202910-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202910-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202910-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202910-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202910-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202910-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202910-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202910-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202910-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202910-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202910-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202910-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202910-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202910-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202910-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202910-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202910-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202910-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202910-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202910-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202910-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202910-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202910-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202910-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202910-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202910-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202910-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Irbesartan
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IRBESARTAN	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J0E2756Z7N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200094	Internal RxNorm lookup
200095	Internal RxNorm lookup
200096	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
61b60f94-35e6-b90b-08ce-fbb2fe011f34	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
34942a29-de4f-d63c-7755-ba18fe1411a0	Product name	6	20180619
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-441-11	Irbesartan	1 in 1 BLISTER PACK	TABLET	1		9
50268-441-15	Irbesartan	50 in 1 BOX, UNIT-DOSE	TABLET	50		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-441-11	EA - Each	50268-441	7dd41205-fe54-4d2a-a580-89e98642ac5a	1	2015-12-02
50268-441-15	EA - Each	50268-441	e7444a5c-bab5-4ad8-a7c1-bd6cd4f3c14f	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IRBESARTAN	ACTIVE INGREDIENT	J0E2756Z7N	IRBESARTAN TABLET [AVPAK]	1
IRBESARTAN	ACTIVE MOIETY	J0E2756Z7N	IRBESARTAN TABLET [AVPAK]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	IRBESARTAN TABLET [AVPAK]	1
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	IRBESARTAN TABLET [AVPAK]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IRBESARTAN TABLET [AVPAK]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IRBESARTAN TABLET [AVPAK]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	IRBESARTAN TABLET [AVPAK]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-441	IRBESARTAN TABLET [AVPAK]	8	Current NDC, Legacy NDC, 2 package rows	20250112_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	5b259fdd-ca4c-49c9-a50d-86066f5b0746	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	7e0ddb7b-80c5-47ab-afee-c74bb735e829	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	21dd9a41-93c7-470c-94ed-f4c24e3d5633	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	Preferred Pharmaceuticals Inc.	197871da-e0c5-49a9-8dd0-34a8c2685c6b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	0c1fc197-c2d9-453c-b79f-b53de89c188b	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	bb58acb0-2dc0-45ee-86bb-b405b1b75cff	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	Camber Pharmaceuticals, Inc.	33416f1e-adee-4a45-b6fe-1fc39044e307	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	AvPAK	61b60f94-35e6-b90b-08ce-fbb2fe011f34	2025-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910 ndc (product): 50268-441
IRBESARTAN	IRBESARTAN	direct rx	bfdf76ae-fedf-630c-e053-2995a90a9868	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	Quality Care Products, LLC	9b8581c1-d052-4fe2-a9fc-cf7adf0f9061	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	5c125c2a-a709-4cf1-b2d5-6e1d24a77377	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	A-S Medication Solutions	9644fa38-dd28-4888-9d55-80967c4fc8d7	2023-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	A-S Medication Solutions	868bd0a7-38ff-4722-8063-a697af3be527	2023-12-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	Proficient Rx LP	950e33da-5e77-40df-b73b-dd084b36a804	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J0E2756Z7N	IRBESARTAN	138402-11-6	IRBESARTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200095	irbesartan 150 MG Oral Tablet	PSN	61b60f94-35e6-b90b-08ce-fbb2fe011f34	9
200096	irbesartan 300 MG Oral Tablet	PSN	61b60f94-35e6-b90b-08ce-fbb2fe011f34	9
200094	irbesartan 75 MG Oral Tablet	PSN	61b60f94-35e6-b90b-08ce-fbb2fe011f34	9
200095	irbesartan 150 MG Oral Tablet	SCD	61b60f94-35e6-b90b-08ce-fbb2fe011f34	9
200096	irbesartan 300 MG Oral Tablet	SCD	61b60f94-35e6-b90b-08ce-fbb2fe011f34	9
200094	irbesartan 75 MG Oral Tablet	SCD	61b60f94-35e6-b90b-08ce-fbb2fe011f34	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50268-441-11	50268044111	1 in 1 BLISTER PACK					Historical
50268-441-15	50268044115	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-441-15) / 1 TABLET in 1 BLISTER PACK (50268-441-11)	50 blister pack	2023-08-08	No	No	Current