Irbesartan

Product NDC: 63187-757
11-digit product format: 631870757
Labeler code: 63187
Product ID: 63187-757_2203d183-4cf9-42a4-94b3-44651a4cbeeb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IRBESARTAN
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA203071
Marketing category: ANDA
Marketing start: 2012-09-27
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63187-757		D	Discontinued by firm	2026-08-17
excluded package	package	63187-757	63187-757-30	D	Discontinued by firm	2026-08-17
excluded package	package	63187-757	63187-757-60	D	Discontinued by firm	2026-08-17
excluded package	package	63187-757	63187-757-90	D	Discontinued by firm	2026-08-17

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 · 8 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	63187-757-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-757-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-757-60	`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	63187-757-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-757-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-757-60	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203071-001	IRBESARTAN	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27
A203071-002	IRBESARTAN	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27
A203071-003	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
A203071-001	AB
A203071-002	AB
A203071-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203071-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203071-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203071-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203071-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203071-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203071-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203071-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203071-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203071-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203071-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203071-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203071-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203071-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203071-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203071-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203071-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203071-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203071-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203071-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203071-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203071-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203071-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203071-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203071-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203071-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203071-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203071-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203071-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203071-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203071-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203071-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203071-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203071-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203071-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203071-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203071-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203071-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203071-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203071-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203071-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203071-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203071-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203071-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-757-30	EA - Each	63187-757	046767ef-a4fa-44e8-8577-b7ec69731045	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-757	IRBESARTAN TABLET [PROFICIENT RX LP]	3	Legacy NDC	20191121_5c83ff4e-271c-4b66-903d-21c8455868c1.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	029a90b6-0722-49be-8400-3ec29526aafd	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203071 application number: ANDA203071
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	9adacfa2-2814-4deb-9e34-c3b3c8dcd41a	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203071 application number: ANDA203071
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	14d85774-2d74-4300-b4bb-c2836db4d5bd	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203071 application number: ANDA203071
Irbesartan	IRBESARTAN	Solco Healthcare U.S., LLC	6916c617-92d2-44f5-b968-6267517a2ce6	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203071 application number: ANDA203071
Irbesartan	IRBESARTAN	A-S Medication Solutions	70a25c6d-23ce-488c-9ef8-62b3b99e5052	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203071 application number: ANDA203071
Irbesartan	IRBESARTAN	A-S Medication Solutions	6babdb48-8384-49ce-a759-d380d79a4010	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203071 application number: ANDA203071
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	ecc490ea-a68e-4261-8be2-5020ac5ab803	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203071 application number: ANDA203071
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	efcd5f2e-1837-44ae-bc91-410c4d8b27c7	2023-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203071 application number: ANDA203071
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	1ab1ff46-d0b1-4762-9ebf-3e07dde8b048	2023-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203071 application number: ANDA203071
Irbesartan	IRBESARTAN	Proficient Rx LP	b587d89b-8ff9-4180-b31a-bbff5d365a1d	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203071 application number: ANDA203071

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-757-30	63187075730	30 TABLET in 1 BOTTLE (63187-757-30)	30 tablet	2016-10-03	0000-00-00	No	No	Current
63187-757-60	63187075760	60 TABLET in 1 BOTTLE (63187-757-60)	60 tablet	2016-10-03	0000-00-00	No	No	Current
63187-757-90	63187075790	90 TABLET in 1 BOTTLE (63187-757-90)	90 tablet	2016-10-03	0000-00-00	No	No	Current