bisoprolol fumarate and hydrochlorothiazide

Product NDC: 33261-918
11-digit product format: 332610918
Labeler code: 33261
Product ID: 33261-918_67b56f89-ea09-427c-95ff-f358b6eb256e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bisoprolol fumarate and hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA079106
Marketing category: ANDA
Marketing start: 2010-10-12
Marketing end: 0000-00-00
Substance: BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength: 5 mg/1; mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	33261-918		I	Inactivated by FDA		2026-10-05
excluded package	package	33261-918	33261-918-60	I	Inactivated by FDA		2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-918-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-918-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-918-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-918-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-918-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-918-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-918-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-918-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-918-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-918-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-918-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-918-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-918-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-918-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-918-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	33261-918-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	33261-918-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	33261-918-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	33261-918-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	33261-918-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	33261-918-60	`9bebd1f3094a…`	`5416666fcb17…`

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
A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28
A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28
A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A079106-001	AB
A079106-002	AB
A079106-003	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 · 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	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079106-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079106-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079106-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2010-07-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A079106-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079106-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079106-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079106-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079106-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079106-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079106-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079106-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079106-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079106-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079106-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079106-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079106-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079106-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079106-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079106-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079106-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079106-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079106-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079106-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079106-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079106-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079106-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079106-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079106-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079106-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079106-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079106-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079106-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079106-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079106-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079106-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079106-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079106-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079106-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079106-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079106-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079106-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079106-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079106-001	AB	1	`301d65b070ca…`

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
97e4a60d-917d-ef62-dc8a-bd557b62b708	Product name	7	20260129
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
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
33261-918-60	2020-01-31	C162847	48780-1	9d75b9d0-ffbb-f424-e053-dadaa90a57ce	Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33261-918-60	bisoprolol fumarate and hydrochlorothiazide	60 in 1 BOTTLE, PLASTIC	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-918-60	EA - Each	33261-918	1153cd84-712e-4782-ab80-cb94521242a0	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISOPROLOL FUMARATE	ACTIVE INGREDIENT	UR59KN573L	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
BISOPROLOL	ACTIVE MOIETY	Y41JS2NL6U	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-918	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	2	Legacy NDC, 1 package rows	20140327_b3afd73f-4640-4a73-aed1-66c46fe533dd.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bisoprolol fumarate and hydrochlorothiazide	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	Unichem Pharmaceuticals (USA), Inc.	b9ee689a-ea12-435d-b01c-70d45891e62f	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079106 application number: ANDA079106
bisoprolol fumarate and hydrochlorothiazide	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	447c11b6-72fe-418e-a2db-5d90b5347796	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079106 application number: ANDA079106
bisoprolol fumarate and hydrochlorothiazide	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	36fbc5fc-4a75-4aa3-bed1-78944135ae11	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079106 application number: ANDA079106

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UR59KN573L	BISOPROLOL FUMARATE	104344-23-2	BISOPROLOL FUMARATE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854919	bisoprolol fumarate 5 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet	PSN	b3afd73f-4640-4a73-aed1-66c46fe533dd	2
854919	bisoprolol fumarate 5 MG / hydrochlorothiazide 6.25 MG Oral Tablet	SCD	b3afd73f-4640-4a73-aed1-66c46fe533dd	2
854919	bisoprolol fumarate 5 MG / HCTZ 6.25 MG Oral Tablet	SY	b3afd73f-4640-4a73-aed1-66c46fe533dd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-918-60	33261091860	60 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP	Aidarex Pharmaceuticals LLC	2013-12-14	HUMAN PRESCRIPTION DRUG LABEL	2