Irbesartan

Product NDC: 72603-671
11-digit product format: 726030671
Labeler code: 72603
Product ID: 72603-671_08c85ada-de6f-4cff-bc81-2332a22bef45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Irbesartan
Dosage form: TABLET
Route: ORAL
Labeler: NorthStar RxLLC
Application: ANDA202254
Marketing category: ANDA
Marketing start: 2026-03-25
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202254-001	IRBESARTAN	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03
A202254-002	IRBESARTAN	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03
A202254-003	IRBESARTAN	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202254-001	AB
A202254-002	AB
A202254-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202254-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202254-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202254-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202254-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202254-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202254-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202254-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202254-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202254-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202254-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202254-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202254-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202254-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202254-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202254-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202254-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202254-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202254-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202254-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202254-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202254-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202254-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202254-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202254-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202254-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202254-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202254-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202254-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202254-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202254-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202254-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202254-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202254-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202254-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202254-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202254-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202254-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202254-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202254-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202254-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202254-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202254-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202254-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Irbesartan
Listing expiration: 2027-12-31

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
08c85ada-de6f-4cff-bc81-2332a22bef45	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
72603-671-01	Irbesartan	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-671-01	EA - Each	72603-671	9c4dd0ca-f58e-484c-ba8c-e83936814788	1	2026-04-20

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan	IRBESARTAN	Macleods Pharmaceuticals Limited	e8635a1c-ae06-4e23-99f7-e704f91d6f43	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202254 application number: ANDA202254
Irbesartan	IRBESARTAN	NorthStar RxLLC	08c85ada-de6f-4cff-bc81-2332a22bef45	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202254 application number: ANDA202254 ndc (product): 72603-671
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	bc07bbf5-b1c6-4854-b6af-e06520c20728	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202254 application number: ANDA202254
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	ed789dc1-0b39-4efc-990d-7b6b43a8b3ba	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202254 application number: ANDA202254
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	44b72da1-4434-461f-8e3c-264ad46f85df	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202254 application number: ANDA202254
Irbesartan	IRBESARTAN	Proficient Rx LP	f0ec2ccc-7d79-4cde-a13e-08faeea4e934	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202254 application number: ANDA202254
Irbesartan	IRBESARTAN	Proficient Rx LP	ada35ec2-8472-411a-8e7c-ff1a0df94ab5	2020-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202254 application number: ANDA202254

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	08c85ada-de6f-4cff-bc81-2332a22bef45	1
200096	irbesartan 300 MG Oral Tablet	PSN	08c85ada-de6f-4cff-bc81-2332a22bef45	1
200094	irbesartan 75 MG Oral Tablet	PSN	08c85ada-de6f-4cff-bc81-2332a22bef45	1
200095	irbesartan 150 MG Oral Tablet	SCD	08c85ada-de6f-4cff-bc81-2332a22bef45	1
200096	irbesartan 300 MG Oral Tablet	SCD	08c85ada-de6f-4cff-bc81-2332a22bef45	1
200094	irbesartan 75 MG Oral Tablet	SCD	08c85ada-de6f-4cff-bc81-2332a22bef45	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72603-671-01	72603067101	90 TABLET in 1 BOTTLE (72603-671-01)	90 tablet	2026-03-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Irbesartan	NorthStar RxLLC \| Macleods Pharmaceuticals Limited	2026-03-31	Human Prescription Drug Label	1