Irbesartan

Product NDC: 43547-376
11-digit product format: 435470376
Labeler code: 43547
Product ID: 43547-376_9dd3ba36-25b6-45da-906f-316049b9f23b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Irbesartan
Dosage form: TABLET
Route: ORAL
Labeler: Solco Healthcare U.S., LLC
Application: ANDA203071
Marketing category: ANDA
Marketing start: 2016-06-13
Substance: IRBESARTAN
Active strength: 300 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 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IRBESARTAN	300 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
6916c617-92d2-44f5-b968-6267517a2ce6	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	SPL version
43547-376-03	Irbesartan	30 in 1 BOTTLE	TABLET	30	7
43547-376-09	Irbesartan	90 in 1 BOTTLE	TABLET	90	7
43547-376-50	Irbesartan	500 in 1 BOTTLE	TABLET	500	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-376-03	EA - Each	43547-376	50a0da29-6c77-4b60-bf37-bdb46b164742	1	2016-10-06
43547-376-09	EA - Each	43547-376	2cb277fb-cfcb-4975-bdeb-f07ac79d52c7	1	2016-10-06
43547-376-50	EA - Each	43547-376	e0e287c9-b620-42f5-a663-fe63bad0aa58	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-376	IRBESARTAN TABLET [SOLCO HEALTHCARE U.S., LLC]	5	Current NDC, Legacy NDC, 3 package rows	20220808_6916c617-92d2-44f5-b968-6267517a2ce6.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 ndc (product): 43547-376
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200095	irbesartan 150 MG Oral Tablet	PSN	6916c617-92d2-44f5-b968-6267517a2ce6	7
200096	irbesartan 300 MG Oral Tablet	PSN	6916c617-92d2-44f5-b968-6267517a2ce6	7
200094	irbesartan 75 MG Oral Tablet	PSN	6916c617-92d2-44f5-b968-6267517a2ce6	7
200095	irbesartan 150 MG Oral Tablet	SCD	6916c617-92d2-44f5-b968-6267517a2ce6	7
200096	irbesartan 300 MG Oral Tablet	SCD	6916c617-92d2-44f5-b968-6267517a2ce6	7
200094	irbesartan 75 MG Oral Tablet	SCD	6916c617-92d2-44f5-b968-6267517a2ce6	7
200096	irbesartan 300 MG Oral Tablet	PSN	70a25c6d-23ce-488c-9ef8-62b3b99e5052	6
200096	irbesartan 300 MG Oral Tablet	PSN	9adacfa2-2814-4deb-9e34-c3b3c8dcd41a	6
200096	irbesartan 300 MG Oral Tablet	PSN	efcd5f2e-1837-44ae-bc91-410c4d8b27c7	6
200096	irbesartan 300 MG Oral Tablet	SCD	70a25c6d-23ce-488c-9ef8-62b3b99e5052	6
200096	irbesartan 300 MG Oral Tablet	SCD	9adacfa2-2814-4deb-9e34-c3b3c8dcd41a	6
200096	irbesartan 300 MG Oral Tablet	SCD	efcd5f2e-1837-44ae-bc91-410c4d8b27c7	6
200096	irbesartan 300 MG Oral Tablet	PSN	6babdb48-8384-49ce-a759-d380d79a4010	1
200096	irbesartan 300 MG Oral Tablet	SCD	6babdb48-8384-49ce-a759-d380d79a4010	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-376-03	43547037603	30 TABLET in 1 BOTTLE (43547-376-03)	30 tablet	2016-06-13	0000-00-00	No	No	Current
43547-376-09	43547037609	90 TABLET in 1 BOTTLE (43547-376-09)	90 tablet	2016-06-13	0000-00-00	No	No	Current
43547-376-50	43547037650	500 TABLET in 1 BOTTLE (43547-376-50)	500 tablet	2016-06-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Irbesartan	REMEDYREPACK INC.	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	7
Irbesartan	Solco Healthcare U.S., LLC \| Prinston Pharmaceutical Inc. \| Zhejiang Huahai Pharmaceutical Co., Ltd.	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	7
Irbesartan	A-S Medication Solutions	2025-08-08	HUMAN PRESCRIPTION DRUG LABEL	6
Irbesartan	A-S Medication Solutions	2025-08-08	HUMAN PRESCRIPTION DRUG LABEL	1
Irbesartan	Bryant Ranch Prepack	2023-11-27	HUMAN PRESCRIPTION DRUG LABEL	6