Bisoprolol Fumarate and Hydrochlorothiazide

Product NDC: 50090-5849
11-digit product format: 500905849
Labeler code: 50090
Product ID: 50090-5849_5abb4d23-ace6-401f-a179-f93b07734002
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bisoprolol Fumarate and Hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA212678
Marketing category: ANDA
Marketing start: 2019-04-30
Marketing end: 0000-00-00
Substance: BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength: 5 mg/1; mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 33 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	50090-5849-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5849-0	`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	50090-5849-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5849-0	`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	50090-5849-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5849-0	`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	50090-5849-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5849-0	`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	50090-5849-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5849-0	`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	50090-5849-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5849-0	`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	50090-5849-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5849-0	`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	50090-5849-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5849-0	`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	50090-5849-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-5849-0	`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	50090-5849-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-5849-0	`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	50090-5849-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-5849-0	`367a005e9d99…`	`383a685ebd0f…`

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

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
A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09
A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09
A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212678-001	AB
A212678-002	AB
A212678-003	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 · 117 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	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212678-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212678-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212678-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2020-07-09	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212678-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212678-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212678-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212678-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212678-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212678-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212678-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212678-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212678-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212678-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212678-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212678-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212678-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212678-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212678-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212678-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212678-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212678-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212678-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212678-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212678-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212678-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212678-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212678-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212678-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212678-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212678-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212678-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212678-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212678-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212678-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212678-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212678-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212678-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212678-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212678-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212678-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212678-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212678-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212678-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BISOPROLOL FUMARATE	5 mg/1
HYDROCHLOROTHIAZIDE	6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UR59KN573L	Internal UNII lookup
0J48LPH2TH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854919	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
12ba7eba-1874-41b6-aff5-7baba8b99984	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-5849-0	2023-02-07	Bisoprolol Fumarate and Hydrochlorothiazide Tablets
50090-5849-0	2023-02-07	Bisoprolol Fumarate and Hydrochlorothiazide Tablets Rx only
50090-5849-2	2023-02-07	Bisoprolol Fumarate and Hydrochlorothiazide Tablets
50090-5849-2	2023-02-07	Bisoprolol Fumarate and Hydrochlorothiazide Tablets Rx only
50090-5849-0	2023-01-30	Bisoprolol Fumarate and Hydrochlorothiazide Tablets
50090-5849-0	2023-01-30	Bisoprolol Fumarate and Hydrochlorothiazide Tablets Rx only
50090-5849-2	2023-01-30	Bisoprolol Fumarate and Hydrochlorothiazide Tablets
50090-5849-2	2023-01-30	Bisoprolol Fumarate and Hydrochlorothiazide Tablets Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5849-0	EA - Each	50090-5849	cda5881d-c940-4d03-a080-7f39e29cd788	1	2022-06-06
50090-5849-2	EA - Each	50090-5849	a5055fbf-9252-45d0-8287-a72c6a472b24	1	2022-06-06

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bisoprolol Fumarate and Hydrochlorothiazide	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	Edenbridge Pharmaceuticals LLC.	295532b5-65c8-40c3-8d27-cfd334d12802	2026-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212678 application number: ANDA212678
Bisoprolol Fumarate and Hydrochlorothiazide	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	53221419-204c-40a2-9ec3-8e4b994dd39d	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212678 application number: ANDA212678
Bisoprolol Fumarate and Hydrochlorothiazide	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	12ba7eba-1874-41b6-aff5-7baba8b99984	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212678 application number: ANDA212678 ndc (product): 50090-5849
Bisoprolol Fumarate and Hydrochlorothiazide	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	154cb1d2-9fb2-4c8d-90de-6a8062a8d1ba	2026-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212678 application number: ANDA212678
Bisoprolol Fumarate and Hydrochlorothiazide	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	6b7f96c3-daf4-4029-a96b-baa37add0edb	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212678 application number: ANDA212678

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UR59KN573L	BISOPROLOL FUMARATE	104344-23-2	BISOPROLOL FUMARATE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5849-0	50090584900	30 TABLET, FILM COATED in 1 BOTTLE (50090-5849-0)	2021-11-08	0000-00-00	No	No	Current
50090-5849-2	50090584902	90 TABLET, FILM COATED in 1 BOTTLE (50090-5849-2)	2021-11-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bisoprolol Fumarate and Hydrochlorothiazide Tablets Rx only	A-S Medication Solutions	2026-08-20	Human Prescription Drug Label	6