Irbesartan and Hydrochlorothiazide

Product NDC: 0093-8238
Requested package NDC: 0093-8238-98
11-digit product format: 000938238
Labeler code: 0093
Product ID: 0093-8238_af80b0d1-ba9d-4d3c-849c-6c7c1a7cfade
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Irbesartan and Hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA077369
Marketing category: ANDA
Marketing start: 2013-01-24
Substance: HYDROCHLOROTHIAZIDE; IRBESARTAN
Active strength: 12.5; 150 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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0093-8238	0093-8238-98	D	Discontinued by firm		2026-09-14

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 · 12 matching rows.

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

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

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

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
A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30
A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30
A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	25MG;300MG	TABLET / ORAL		2012-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077369-001	AB
A077369-002	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 4 · 129 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	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`301d65b070ca…`

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	A077369-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077369-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077369-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077369-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077369-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077369-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077369-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077369-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077369-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077369-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077369-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077369-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077369-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077369-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077369-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077369-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077369-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077369-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077369-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077369-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077369-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077369-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077369-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077369-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077369-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077369-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077369-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077369-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077369-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077369-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077369-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077369-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077369-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077369-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077369-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077369-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077369-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077369-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077369-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077369-002	AB	1	`74a2ff9319b5…`

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	150 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
83f4acc1-697a-4770-b554-1b9a8fb5de74	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
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
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
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
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
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-8238-56	Irbesartan and Hydrochlorothiazide	30 in 1 BOTTLE	TABLET, FILM COATED	30		16
0093-8238-98	Irbesartan and Hydrochlorothiazide	90 in 1 BOTTLE	TABLET, FILM COATED	90		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-8238-56	EA - Each	0093-8238	3e7ff237-1c22-4aaf-b58d-5c39b20f6670	1	2013-02-13
0093-8238-98	EA - Each	0093-8238	ec4bba1f-afa7-457c-80eb-819f722b7a1a	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
IRBESARTAN	ACTIVE INGREDIENT	J0E2756Z7N	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
IRBESARTAN	ACTIVE MOIETY	J0E2756Z7N	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
IRBESARTAN	ACTIVE INGREDIENT	J0E2756Z7N	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
IRBESARTAN	ACTIVE MOIETY	J0E2756Z7N	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
Hypromellose 2910 (5 Mpa.s)	INACTIVE INGREDIENT	R75537T0T4	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
Polyethylene Glycol 6000	INACTIVE INGREDIENT	30IQX730WE	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-8238	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20211203_83f4acc1-697a-4770-b554-1b9a8fb5de74.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5eabb13d-f6fd-4091-9909-c4f0c5922289	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077369 application number: ANDA077369
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5029c9f7-6233-4a6f-ace9-2268cc8e286d	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077369 application number: ANDA077369
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Teva Pharmaceuticals USA, Inc.	83f4acc1-697a-4770-b554-1b9a8fb5de74	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077369 application number: ANDA077369 ndc (package): 0093-8238-98 ndc (product): 0093-8238 ndc11 (package): 00093823898
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	c5f26357-40f3-49f4-99f2-845a8dda5f39	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077369 application number: ANDA077369

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310792	irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	5029c9f7-6233-4a6f-ace9-2268cc8e286d	101
310792	hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet	SCD	5029c9f7-6233-4a6f-ace9-2268cc8e286d	101
310792	HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet	SY	5029c9f7-6233-4a6f-ace9-2268cc8e286d	101
310792	irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	83f4acc1-697a-4770-b554-1b9a8fb5de74	16
310793	irbesartan 300 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	83f4acc1-697a-4770-b554-1b9a8fb5de74	16
310792	hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet	SCD	83f4acc1-697a-4770-b554-1b9a8fb5de74	16
310793	hydrochlorothiazide 12.5 MG / irbesartan 300 MG Oral Tablet	SCD	83f4acc1-697a-4770-b554-1b9a8fb5de74	16
310792	HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet	SY	83f4acc1-697a-4770-b554-1b9a8fb5de74	16
310793	HCTZ 12.5 MG / irbesartan 300 MG Oral Tablet	SY	83f4acc1-697a-4770-b554-1b9a8fb5de74	16
310792	irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	5eabb13d-f6fd-4091-9909-c4f0c5922289	4
310792	hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet	SCD	5eabb13d-f6fd-4091-9909-c4f0c5922289	4
310792	HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet	SY	5eabb13d-f6fd-4091-9909-c4f0c5922289	4
310792	irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	c5f26357-40f3-49f4-99f2-845a8dda5f39	3
310792	hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet	SCD	c5f26357-40f3-49f4-99f2-845a8dda5f39	3
310792	HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet	SY	c5f26357-40f3-49f4-99f2-845a8dda5f39	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-8238-98	00093823898	90 TABLET, FILM COATED in 1 BOTTLE (0093-8238-98)	2013-02-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Irbesartan and Hydrochlorothiazide	Bryant Ranch Prepack	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	5
Irbesartan and Hydrochlorothiazide	Bryant Ranch Prepack	2026-04-07	HUMAN PRESCRIPTION DRUG LABEL	101
Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL	16
Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	2024-02-28	HUMAN PRESCRIPTION DRUG LABEL	7
Irbesartan and Hydrochlorothiazide	AvKARE	2021-07-13	HUMAN PRESCRIPTION DRUG LABEL	5
Irbesartan and Hydrochlorothiazide	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3