BISOPROLOL FUMARATE

Product NDC: 61919-787
Requested package NDC: 61919-787-90
11-digit product format: 619190787
Labeler code: 61919
Product ID: 61919-787_849ef938-5310-a4d2-e053-2991aa0a1c70
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BISOPROLOL FUMARATE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECTRX
Application: ANDA078635
Marketing category: ANDA
Marketing start: 2019-03-21
Marketing end: 0000-00-00
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-787	61919-787-90	I	Inactivated by FDA		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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-787-90	2025-01-30	C162847	48780-1	2cef2736-8d37-d83d-e063-dadaa90ab31f	BISOPROLOL FUMARATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-787-90	BISOPROLOL FUMARATE	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-787-90	EA - Each	61919-787	ef59b3e6-61e7-45b2-ab32-5de55cd5e800	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-787	BISOPROLOL FUMARATE TABLET [DIRECTRX]	1	Legacy NDC, 1 package rows	20190328_849ef938-530f-a4d2-e053-2991aa0a1c70.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
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	849ef938-530f-a4d2-e053-2991aa0a1c70	1
854905	bisoprolol fumarate 5 MG Oral Tablet	SCD	849ef938-530f-a4d2-e053-2991aa0a1c70	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-787-90	61919078790	90 TABLET in 1 BOTTLE (61919-787-90)	90 tablet	2019-03-21	0000-00-00	No	No	Current