bisoprolol fumarate

Product NDC: 0185-0774
11-digit product format: 001850774
Labeler code: 0185
Product ID: 0185-0774_15d8ea4a-9105-46af-9b44-7ea7726c3691
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bisoprolol fumarate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Eon Labs, Inc.
Application: ANDA075643
Marketing category: ANDA
Marketing start: 2000-11-16
Marketing end: 2021-06-30
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	0185-0774		D	Discontinued by firm	2026-08-03
excluded package	package	0185-0774	0185-0774-01	D	Discontinued by firm	2026-08-03
excluded package	package	0185-0774	0185-0774-30	D	Discontinued by firm	2026-08-03

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	0185-0774-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0185-0774-01	`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	0185-0774-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0185-0774-01	`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	0185-0774-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0185-0774-01	`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	0185-0774-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0185-0774-01	`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	0185-0774-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0185-0774-01	`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	0185-0774-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0185-0774-01	`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	0185-0774-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0185-0774-01	`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	0185-0774-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0185-0774-01	`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	0185-0774-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0185-0774-01	`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	0185-0774-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0185-0774-01	`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	0185-0774-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0185-0774-01	`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	0185-0774-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0185-0774-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075643-001	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16
A075643-002	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16
A075643-003	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	2.5MG	TABLET / ORAL		2025-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075643-001	AB
A075643-002	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 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
2026-02-19 14:30 UTC	2026-02	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075643-003	BISOPROLOL FUMARATE	2.5MG	TABLET / ORAL		2025-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075643-003	BISOPROLOL FUMARATE	2.5MG	TABLET / ORAL		2025-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075643-003	BISOPROLOL FUMARATE	2.5MG	TABLET / ORAL		2025-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075643-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075643-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075643-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075643-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075643-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075643-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075643-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075643-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075643-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075643-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075643-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075643-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075643-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075643-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075643-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075643-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075643-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075643-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075643-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075643-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075643-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075643-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075643-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075643-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075643-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075643-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075643-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075643-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075643-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075643-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075643-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075643-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075643-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075643-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075643-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075643-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075643-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075643-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075643-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075643-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0185-0774-01	EA - Each	0185-0774	62e6d72a-0695-4cc6-a5be-6f77544a9a4c	1	2012-07-24
0185-0774-30	EA - Each	0185-0774	4613932e-e61f-4e51-b98b-eb8af3d97fdc	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, COATED [EON LABS, INC.]	17
BISOPROLOL	ACTIVE MOIETY	Y41JS2NL6U	BISOPROLOL FUMARATE TABLET, COATED [EON LABS, INC.]	17
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BISOPROLOL FUMARATE TABLET, COATED [EON LABS, INC.]	17
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BISOPROLOL FUMARATE TABLET, COATED [EON LABS, INC.]	17
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BISOPROLOL FUMARATE TABLET, COATED [EON LABS, INC.]	17
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BISOPROLOL FUMARATE TABLET, COATED [EON LABS, INC.]	17
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BISOPROLOL FUMARATE TABLET, COATED [EON LABS, INC.]	17
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BISOPROLOL FUMARATE TABLET, COATED [EON LABS, INC.]	17
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BISOPROLOL FUMARATE TABLET, COATED [EON LABS, INC.]	17
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BISOPROLOL FUMARATE TABLET, COATED [EON LABS, INC.]	17
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BISOPROLOL FUMARATE TABLET, COATED [EON LABS, INC.]	17
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BISOPROLOL FUMARATE TABLET, COATED [EON LABS, INC.]	17
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BISOPROLOL FUMARATE TABLET, COATED [EON LABS, INC.]	17

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	BISOPROLOL FUMARATE	Bryant Ranch Prepack	6ebe6ec0-6223-425c-9f3b-8ab8dd8b3f5f	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075643 application number: ANDA075643
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Advagen Pharma Ltd	83e4b4e5-9130-44c8-abab-fcd0db5d8c49	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075643 application number: ANDA075643
Bisoprolol Fumarate	BISOPROLOL FUMARATE	TruPharma LLC	0ef9e45c-21ee-4e00-a9b8-280e2035b4d3	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075643 application number: ANDA075643

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0185-0774-01	00185077401	100 TABLET, COATED in 1 BOTTLE (0185-0774-01)	2000-11-16	2021-05-31	No	No	Current
0185-0774-30	00185077430	30 TABLET, COATED in 1 BOTTLE (0185-0774-30)	2000-11-16	2021-06-30	No	No	Current