Irbesartan and Hydrochlorothiazide

Product NDC: 68645-405
11-digit product format: 686450405
Labeler code: 68645
Product ID: 68645-405_63e83822-798e-46e0-87bf-45e9d2910184
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Irbesartan and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Legacy Pharmaceutical Packaging
Application: ANDA077369
Marketing category: ANDA
Marketing start: 2012-03-30
Marketing end: 0000-00-00
Substance: IRBESARTAN; HYDROCHLOROTHIAZIDE
Active strength: 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: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68645-405		I	Inactivated by FDA		2026-09-14
excluded package	package	68645-405	68645-405-70	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68645-405-70	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68645-405-70	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68645-405-70	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68645-405-70	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68645-405-70	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68645-405-70	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68645-405-70	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68645-405-70	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68645-405-70	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68645-405-70	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68645-405-70	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68645-405-70	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68645-405-70	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68645-405-70	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68645-405-70	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68645-405-70	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68645-405-70	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68645-405-70	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68645-405-70	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68645-405-70	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68645-405-70	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68645-405-70	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68645-405-70	2020-01-31	C162847	48780-1	9d75b9d0-b3aa-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use irbesartan and hydrochlorothiazide tablets USP safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets USP. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets USP for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68645-405-70	Irbesartan and Hydrochlorothiazide	30 in 1 DOSE PACK	TABLET	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68645-405-70	EA - Each	68645-405	72aeded1-6163-4c25-b8e8-663bfe451ac2	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4
IRBESARTAN	ACTIVE INGREDIENT	J0E2756Z7N	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4
IRBESARTAN	ACTIVE MOIETY	J0E2756Z7N	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68645-405	IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]	4	Legacy NDC, 1 package rows	20121005_2f29f67a-2918-4318-9cb1-5e0eb22b35a3.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
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
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
310792	irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	2f29f67a-2918-4318-9cb1-5e0eb22b35a3	4
310792	hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet	SCD	2f29f67a-2918-4318-9cb1-5e0eb22b35a3	4
310792	HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet	SY	2f29f67a-2918-4318-9cb1-5e0eb22b35a3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68645-405-70	68645040570	30 in 1 DOSE PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Irbesartan and Hydrochlorothiazide	Legacy Pharmaceutical Packaging	2012-10-05	HUMAN PRESCRIPTION DRUG LABEL	4