BISOPROLOL FUMARATE

Product NDC: 15955-373
Requested package NDC: 15955-373-30
11-digit product format: 159550373
Labeler code: 15955
Product ID: 15955-373_b6340ba8-e8d5-4d13-bcfa-d1a0cea085d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BISOPROLOL FUMARATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alembic Labs LLC
Application: ANDA204891
Marketing category: ANDA
Marketing start: 2019-09-11
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: 2021-12-31
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	15955-373	15955-373-30	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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
A204891-001	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2017-01-11
A204891-002	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB		2017-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204891-001	AB
A204891-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`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	A204891-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204891-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204891-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204891-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204891-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204891-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204891-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204891-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204891-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204891-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204891-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204891-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204891-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204891-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204891-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204891-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204891-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204891-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204891-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204891-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204891-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204891-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204891-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204891-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204891-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204891-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204891-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204891-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204891-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204891-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204891-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204891-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204891-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204891-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204891-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204891-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204891-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204891-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204891-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204891-002	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
15955-373-30	2022-01-28	C162847	48780-1	d6a99b39-99d2-a426-e053-dadaa90af4c2	BISOPROLOL FUMARATE Tablets, USP Rx only
15955-373-50	2022-01-28	C162847	48780-1	d6a99b39-99d2-a426-e053-dadaa90af4c2	BISOPROLOL FUMARATE Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
15955-373-30	BISOPROLOL FUMARATE	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		2
15955-373-50	BISOPROLOL FUMARATE	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15955-373	BISOPROLOL FUMARATE TABLET, FILM COATED [ALEMBIC LABS LLC]	2	Legacy NDC, 2 package rows	20201127_230b6ffb-0586-4e80-962c-80058c1a14bd.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	Alembic Pharmaceuticals Limited	ae10b8e1-557d-4437-8a1d-89d7844122c8	2023-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204891 application number: ANDA204891
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	Alembic Pharmaceuticals Inc.	9b2eb4ea-001e-436c-93ba-20a7f5bc5f04	2021-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204891 application number: ANDA204891

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
854901	bisoprolol fumarate 10 MG Oral Tablet	PSN	230b6ffb-0586-4e80-962c-80058c1a14bd	2
854905	bisoprolol fumarate 5 MG Oral Tablet	PSN	230b6ffb-0586-4e80-962c-80058c1a14bd	2
854901	bisoprolol fumarate 10 MG Oral Tablet	SCD	230b6ffb-0586-4e80-962c-80058c1a14bd	2
854905	bisoprolol fumarate 5 MG Oral Tablet	SCD	230b6ffb-0586-4e80-962c-80058c1a14bd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
15955-373-30	15955037330	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15955-373-30)	2019-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BISOPROLOL FUMARATE Tablets, USP Rx only	Alembic Labs LLC \| Skyepharma Production S.A.S.	2020-11-10	Human Prescription Drug Label	2