Irbesartan

Product NDC: 0054-0251
11-digit product format: 000540251
Labeler code: 0054
Product ID: 0054-0251_7d783004-ef17-4dcb-a3d9-4a965116ad4c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Irbesartan
Dosage form: TABLET
Route: ORAL
Labeler: West-Ward Pharmaceuticals Corp.
Application: ANDA090201
Marketing category: ANDA
Marketing start: 2012-10-15
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0054-0251		D	Discontinued by firm	2026-08-10
excluded package	package	0054-0251	0054-0251-13	D	Discontinued by firm	2026-08-10
excluded package	package	0054-0251	0054-0251-22	D	Discontinued by firm	2026-08-10

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0054-0251-22	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0054-0251-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0054-0251-22	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0054-0251-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0054-0251-22	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0054-0251-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0054-0251-22	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0054-0251-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0054-0251-22	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0054-0251-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0054-0251-22	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0054-0251-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0054-0251-22	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0054-0251-13	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-0251-22	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-0251-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-0251-22	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-0251-13	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0054-0251-22	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0054-0251-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0054-0251-22	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0054-0251-13	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0054-0251-22	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0054-0251-13	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A090201-001	IRBESARTAN	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15
A090201-002	IRBESARTAN	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15
A090201-003	IRBESARTAN	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090201-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090201-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090201-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090201-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090201-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090201-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090201-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090201-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090201-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090201-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090201-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090201-003	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0251-13	EA - Each	0054-0251	b68d102f-04e2-444b-bef8-032a69f05ff0	1	2013-02-13
0054-0251-22	EA - Each	0054-0251	9c5249a9-701c-4158-aebb-f2b2ff98b445	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IRBESARTAN	ACTIVE INGREDIENT	J0E2756Z7N	IRBESARTAN TABLET [ROXANE LABORATORIES, INC.]	2
IRBESARTAN	ACTIVE MOIETY	J0E2756Z7N	IRBESARTAN TABLET [ROXANE LABORATORIES, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IRBESARTAN TABLET [ROXANE LABORATORIES, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IRBESARTAN TABLET [ROXANE LABORATORIES, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	IRBESARTAN TABLET [ROXANE LABORATORIES, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IRBESARTAN TABLET [ROXANE LABORATORIES, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IRBESARTAN TABLET [ROXANE LABORATORIES, INC.]	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Irbesartan	West-Ward Pharmaceuticals Corp. \| West-Ward Columbus Inc.	2019-01-04	HUMAN PRESCRIPTION DRUG LABEL	6