Irbesartan and Hydrochlorothiazide

Product NDC: 43547-672
11-digit product format: 435470672
Labeler code: 43547
Product ID: 43547-672_da1c9acf-6323-4ef5-bfff-8eedc7992d78
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Irbesartan and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Solco Healthcare US, LLC
Application: ANDA203072
Marketing category: ANDA
Marketing start: 2014-03-01
Marketing end: 0000-00-00
Substance: HYDROCHLOROTHIAZIDE; IRBESARTAN
Active strength: 25 mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;150MG	TABLET / ORAL	AB		2014-05-09
A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;300MG	TABLET / ORAL	AB		2014-05-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203072-001	AB
A203072-002	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 3 · 86 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	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A203072-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203072-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203072-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203072-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203072-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203072-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203072-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203072-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203072-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203072-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203072-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203072-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203072-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203072-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203072-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203072-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203072-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203072-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203072-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203072-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203072-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203072-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203072-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203072-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203072-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203072-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203072-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203072-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203072-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203072-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203072-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203072-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203072-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203072-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203072-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203072-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203072-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203072-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203072-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203072-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	88aaa2a1-13be-4f56-ace6-66e899028007	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203072 application number: ANDA203072
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	85494404-484c-45a1-8487-f9eb2a76490d	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203072 application number: ANDA203072
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Solco Healthcare US, LLC	72fa8cd4-bc2a-4a7d-8feb-2d60e077d801	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203072 application number: ANDA203072
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	53ce6e4f-db3a-4789-8bef-1e459fa78b79	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203072 application number: ANDA203072
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	c7ce5a69-1e07-4d52-b815-ce64ac3731ac	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203072 application number: ANDA203072

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
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
43547-672-03	43547067203	30 TABLET in 1 BOTTLE (43547-672-03)	30 tablet	2014-03-01	0000-00-00	No	No	Current
43547-672-09	43547067209	90 TABLET in 1 BOTTLE (43547-672-09)	90 tablet	2014-03-01	0000-00-00	No	No	Current
43547-672-50	43547067250	500 TABLET in 1 BOTTLE (43547-672-50)	500 tablet	2014-03-01	0000-00-00	No	No	Current