Bisoprolol Fumarate

Product NDC: 68788-8671
11-digit product format: 687888671
Labeler code: 68788
Product ID: 68788-8671_56ee5e1d-4ca1-44de-be60-34563e10c2a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bisoprolol fumarate
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA078635
Marketing category: ANDA
Marketing start: 2024-05-21
Substance: BISOPROLOL FUMARATE
Active strength: 5 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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
A078635-001	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18
A078635-002	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078635-001	AB
A078635-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`782e0a99824c…`

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	A078635-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078635-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078635-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078635-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078635-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078635-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078635-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078635-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078635-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078635-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078635-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078635-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078635-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078635-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078635-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078635-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078635-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078635-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078635-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078635-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078635-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078635-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078635-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078635-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078635-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078635-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078635-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078635-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078635-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078635-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078635-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078635-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078635-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078635-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078635-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078635-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078635-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078635-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078635-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078635-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bisoprolol Fumarate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BISOPROLOL FUMARATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UR59KN573L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854905	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c0e309f3-82c3-4629-b790-fb8538b87369	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
97e4a60d-917d-ef62-dc8a-bd557b62b708	Product name	7	20260129
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8671-1	Bisoprolol Fumarate	100 in 1 BOTTLE, PLASTIC	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8671-1	EA - Each	68788-8671	1acd384e-e351-4d2b-9999-9000092b5093	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8671	BISOPROLOL FUMARATE TABLET [PREFERRED PHARMACEUTICALS INC.]	2	Current NDC, 1 package rows	20250210_c0e309f3-82c3-4629-b790-fb8538b87369.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Preferred Pharmaceuticals Inc.	c0e309f3-82c3-4629-b790-fb8538b87369	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078635 application number: ANDA078635 ndc (product): 68788-8671
Bisoprolol Fumarate	BISOPROLOL FUMARATE	American Health Packaging	36b53e7f-e306-40a8-8d1b-d00695a4fe61	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078635 application number: ANDA078635
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Bryant Ranch Prepack	428ef54d-8828-4756-a087-a1b7b2d6b8d6	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078635 application number: ANDA078635
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Bryant Ranch Prepack	4f11e64c-732e-419a-bc29-9cd2ff86d0b9	2023-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078635 application number: ANDA078635
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Unichem Pharmaceuticals (USA), Inc.	4f20df45-3f9c-4a91-b394-e93a08111ec3	2022-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078635 application number: ANDA078635
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Proficient Rx LP	bce7e65a-148f-4ccd-9305-bc7331dbcca4	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078635 application number: ANDA078635

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854905	bisoprolol fumarate 5 MG Oral Tablet	PSN	c0e309f3-82c3-4629-b790-fb8538b87369	3
854905	bisoprolol fumarate 5 MG Oral Tablet	SCD	c0e309f3-82c3-4629-b790-fb8538b87369	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8671-1	68788867101	100 TABLET in 1 BOTTLE, PLASTIC (68788-8671-1)	100 tablet	2024-05-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bisoprolol Fumarate Tablets USP	Preferred Pharmaceuticals Inc.	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	3