Irbesartan and Hydrochlorothiazide

Product NDC: 43547-331
11-digit product format: 435470331
Labeler code: 43547
Product ID: 43547-331_eac8a790-f699-409f-adca-224341b082e0
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
Substance: IRBESARTAN; HYDROCHLOROTHIAZIDE
Active strength: 300; 12.5 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: 2027-12-31
Current FDA listing: Yes

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 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A203072-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203072-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203072-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203072-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203072-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203072-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203072-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203072-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203072-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203072-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203072-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203072-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203072-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203072-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203072-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203072-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203072-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203072-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203072-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203072-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203072-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203072-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203072-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203072-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203072-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203072-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203072-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203072-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203072-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203072-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203072-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203072-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203072-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203072-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203072-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203072-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203072-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203072-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203072-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203072-002	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Irbesartan and Hydrochlorothiazide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IRBESARTAN	300 mg/1
HYDROCHLOROTHIAZIDE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J0E2756Z7N	Internal UNII lookup
0J48LPH2TH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310792	Internal RxNorm lookup
310793	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
72fa8cd4-bc2a-4a7d-8feb-2d60e077d801	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
34942a29-de4f-d63c-7755-ba18fe1411a0	Product name	6	20180619
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
43547-331-03	2020-04-23	These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-331-03	2020-04-23	These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-331-09	2020-04-23	These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-331-09	2020-04-23	These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-331-50	2020-04-23	These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-331-50	2020-04-23	These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-331-03	2020-01-31	These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-331-03	2020-01-31	These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-331-09	2020-01-31	These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-331-09	2020-01-31	These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-331-50	2020-01-31	These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-331-50	2020-01-31	These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE 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
43547-331-03	Irbesartan and Hydrochlorothiazide	30 in 1 BOTTLE	TABLET	30	11
43547-331-09	Irbesartan and Hydrochlorothiazide	90 in 1 BOTTLE	TABLET	90	11
43547-331-50	Irbesartan and Hydrochlorothiazide	500 in 1 BOTTLE	TABLET	500	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-331-03	EA - Each	43547-331	5504fb4c-48d6-49f9-8878-3b3852669afb	1	2014-06-03
43547-331-09	EA - Each	43547-331	d712cff5-1a8c-41f6-9674-399cd49a8e09	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
IRBESARTAN	ACTIVE INGREDIENT	J0E2756Z7N	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
IRBESARTAN	ACTIVE MOIETY	J0E2756Z7N	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-331	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC]	9	Current NDC, Legacy NDC, 3 package rows	20250426_72fa8cd4-bc2a-4a7d-8feb-2d60e077d801.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 · 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 ndc (product): 43547-331
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
J0E2756Z7N	IRBESARTAN	138402-11-6	IRBESARTAN
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310793	irbesartan 300 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	88aaa2a1-13be-4f56-ace6-66e899028007	12
310793	hydrochlorothiazide 12.5 MG / irbesartan 300 MG Oral Tablet	SCD	88aaa2a1-13be-4f56-ace6-66e899028007	12
310793	HCTZ 12.5 MG / irbesartan 300 MG Oral Tablet	SY	88aaa2a1-13be-4f56-ace6-66e899028007	12
310792	irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	72fa8cd4-bc2a-4a7d-8feb-2d60e077d801	11
310793	irbesartan 300 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	72fa8cd4-bc2a-4a7d-8feb-2d60e077d801	11
310792	hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet	SCD	72fa8cd4-bc2a-4a7d-8feb-2d60e077d801	11
310793	hydrochlorothiazide 12.5 MG / irbesartan 300 MG Oral Tablet	SCD	72fa8cd4-bc2a-4a7d-8feb-2d60e077d801	11
310792	HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet	SY	72fa8cd4-bc2a-4a7d-8feb-2d60e077d801	11
310793	HCTZ 12.5 MG / irbesartan 300 MG Oral Tablet	SY	72fa8cd4-bc2a-4a7d-8feb-2d60e077d801	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-331-03	43547033103	30 TABLET in 1 BOTTLE (43547-331-03)	30 tablet	2014-03-01	0000-00-00	No	No	Current
43547-331-09	43547033109	90 TABLET in 1 BOTTLE (43547-331-09)	90 tablet	2014-03-01	0000-00-00	No	No	Current
43547-331-50	43547033150	500 TABLET in 1 BOTTLE (43547-331-50)	500 tablet	2014-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	13
Irbesartan and Hydrochlorothiazide	Solco Healthcare US, LLC	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	12