Bisoprolol Fumarate and Hydrochlorothiazide

Product NDC: 43063-134
11-digit product format: 430630134
Labeler code: 43063
Product ID: 43063-134_7c48327c-4ee5-1990-e053-2991aa0a7635
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bisoprolol fumarate and hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA075768
Marketing category: ANDA
Marketing start: 2000-09-25
Marketing end: 0000-00-00
Substance: BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength: 10 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43063-134		D	Discontinued by firm	2026-10-05
excluded package	package	43063-134	43063-134-30	D	Discontinued by firm	2026-10-05
excluded package	package	43063-134	43063-134-90	D	Discontinued by firm	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 · 36 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	43063-134-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-134-30	`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	43063-134-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-134-30	`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	43063-134-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-134-30	`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	43063-134-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-134-30	`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	43063-134-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-134-30	`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	43063-134-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-134-30	`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	43063-134-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-134-30	`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	43063-134-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-134-30	`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	43063-134-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-134-30	`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	43063-134-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-134-30	`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	43063-134-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43063-134-30	`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	43063-134-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43063-134-30	`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
A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25
A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25
A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075768-001	AB
A075768-002	AB
A075768-003	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	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075768-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075768-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075768-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2000-09-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 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	A075768-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075768-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075768-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075768-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075768-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075768-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075768-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075768-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075768-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075768-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075768-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075768-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075768-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075768-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075768-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075768-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075768-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075768-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075768-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075768-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075768-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075768-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075768-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075768-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075768-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075768-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075768-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075768-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075768-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075768-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075768-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075768-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075768-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075768-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075768-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075768-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075768-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075768-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075768-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075768-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-134-30	EA - Each	43063-134	6956d848-ed04-48f6-ae53-3afae053b9d0	1	2012-07-24
43063-134-90	EA - Each	43063-134	2201f215-bce1-4754-aca0-cc5af1a8f6b6	1	2012-07-24

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 · 1 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	Mylan Pharmaceuticals Inc.	d4243a76-516c-417e-80ba-444a21ecc688	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075768 application number: ANDA075768

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