IRBESARTAN

Product NDC: 71335-0423
Requested package NDC: 71335-0423-3
11-digit product format: 713350423
Labeler code: 71335
Product ID: 71335-0423_01c9caf2-97f7-4d48-8599-51fc54047046
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IRBESARTAN
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091236
Marketing category: ANDA
Marketing start: 2016-07-01
Marketing end: 0000-00-00
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-0423	71335-0423-3	I	Inactivated by FDA		2026-08-11

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A091236-001	IRBESARTAN	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15
A091236-002	IRBESARTAN	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15
A091236-003	IRBESARTAN	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091236-001	AB
A091236-002	AB
A091236-003	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	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091236-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091236-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091236-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`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	A091236-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091236-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091236-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091236-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091236-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091236-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091236-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091236-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091236-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091236-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091236-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091236-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091236-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091236-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091236-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091236-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091236-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091236-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091236-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091236-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091236-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091236-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091236-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091236-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091236-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091236-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091236-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091236-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091236-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091236-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091236-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091236-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091236-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091236-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091236-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091236-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091236-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091236-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091236-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091236-001	AB	1	`8072bd15b7f6…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71335-0423-1	2024-01-30	C162847	48780-1	1030e365-5b91-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997
71335-0423-2	2024-01-30	C162847	48780-1	1030e365-5b91-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997
71335-0423-3	2024-01-30	C162847	48780-1	1030e365-5b91-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0423-1	IRBESARTAN	30 in 1 BOTTLE	TABLET	30	6
71335-0423-2	IRBESARTAN	60 in 1 BOTTLE	TABLET	60	6
71335-0423-3	IRBESARTAN	90 in 1 BOTTLE	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0423-1	EA - Each	71335-0423	097e3bd3-99a4-4cbd-9ed5-2d58e777a23e	1	2018-03-08
71335-0423-2	EA - Each	71335-0423	7238f51b-ff89-40ad-ac66-9df13744fc5f	1	2018-03-08
71335-0423-3	EA - Each	71335-0423	9a4c725d-1c42-41a1-892c-6f396fe5a068	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0423	IRBESARTAN TABLET [BRYANT RANCH PREPACK]	6	Legacy NDC, 3 package rows	20220129_01c9caf2-97f7-4d48-8599-51fc54047046.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IRBESARTAN	IRBESARTAN	Alembic Pharmaceuticals Inc.	83f5d5c8-27c0-4208-a291-0c4aa55a1ff5	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091236 application number: ANDA091236
IRBESARTAN	IRBESARTAN	Alembic Pharmaceuticals Limited	0898f423-0aa9-409c-8d4e-1349b59141d1	2022-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091236 application number: ANDA091236

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	01c9caf2-97f7-4d48-8599-51fc54047046	6
200095	irbesartan 150 MG Oral Tablet	SCD	01c9caf2-97f7-4d48-8599-51fc54047046	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0423-3	71335042303	90 TABLET in 1 BOTTLE (71335-0423-3)	90 tablet	2021-12-27	0000-00-00	No	No	Current