Bisoprolol Fumarate

Product NDC: 0378-0524
11-digit product format: 003780524
Labeler code: 0378
Product ID: 0378-0524_df710284-e519-4d94-aaca-476d3745f7fd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bisoprolol fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA075831
Marketing category: ANDA
Marketing start: 2012-09-24
Marketing end: 2020-11-30
Substance: BISOPROLOL FUMARATE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0378-0524		D	Discontinued by firm	2026-10-05
excluded package	package	0378-0524	0378-0524-01	D	Discontinued by firm	2026-10-05
excluded package	package	0378-0524	0378-0524-93	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	0378-0524-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-0524-01	`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	0378-0524-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-0524-01	`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	0378-0524-93	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-0524-01	`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	0378-0524-93	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-0524-01	`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	0378-0524-93	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-0524-01	`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	0378-0524-93	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-0524-01	`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	0378-0524-93	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-0524-01	`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	0378-0524-93	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-0524-01	`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	0378-0524-93	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-0524-01	`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	0378-0524-93	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-0524-01	`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	0378-0524-93	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-0524-01	`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	0378-0524-93	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-0524-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075831-001	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET / ORAL			2005-12-14
A075831-002	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET / ORAL			2005-12-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2005-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2005-12-14	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075831-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075831-002	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A075831-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075831-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075831-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075831-002	AB	1	`ea99ee380514…`

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
0378-0524-01	EA - Each	0378-0524	bf04d0fc-8e53-4322-9959-148d3a660e18	1	2012-07-24
0378-0524-93	EA - Each	0378-0524	9187b158-7fdf-4582-a778-6e8362ff798b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISOPROLOL FUMARATE	ACTIVE INGREDIENT	UR59KN573L	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
BISOPROLOL	ACTIVE MOIETY	Y41JS2NL6U	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BISOPROLOL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	3

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	BISOPROLOL FUMARATE	Natco Pharma USA LLC	e907bfcb-5e64-45b8-ae9d-822b3d360104	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075831 application number: ANDA075831

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UR59KN573L	BISOPROLOL FUMARATE	104344-23-2	BISOPROLOL FUMARATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bisoprolol Fumarate - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2018-01-16	HUMAN PRESCRIPTION DRUG LABEL	8