Doxazosin

Product NDC: 50090-8055
11-digit product format: 500908055
Labeler code: 50090
Product ID: 50090-8055_51d7e507-0e37-4afb-96de-9fb1d266d6dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxazosin
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA205210
Marketing category: ANDA
Marketing start: 2018-02-13
Substance: DOXAZOSIN MESYLATE
Active strength: 4 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA], alpha-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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205210-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-13
A205210-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-02-13
A205210-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-02-13
A205210-004	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A205210-001	AB
A205210-002	AB
A205210-003	AB
A205210-004	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 5 · 172 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	A205210-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205210-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205210-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205210-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205210-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205210-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205210-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205210-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205210-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205210-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205210-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205210-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205210-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205210-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205210-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205210-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205210-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205210-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205210-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205210-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205210-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205210-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205210-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205210-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205210-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205210-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205210-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205210-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205210-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205210-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205210-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205210-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205210-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205210-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205210-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205210-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205210-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205210-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205210-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205210-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-02-13	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A205210-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205210-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205210-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205210-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205210-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205210-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205210-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205210-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205210-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205210-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205210-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205210-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205210-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205210-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205210-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205210-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205210-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205210-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205210-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205210-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205210-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205210-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205210-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205210-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205210-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205210-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205210-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205210-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205210-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205210-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205210-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205210-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205210-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205210-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205210-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205210-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205210-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205210-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205210-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205210-004	AB	1	`5bbf6a4d5a75…`

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: Doxazosin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXAZOSIN MESYLATE	4 mg/1

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
Doxazosin	DOXAZOSIN	Golden State Medical Supply, Inc.	54eeef3d-c906-37e7-e063-6294a90afca2	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205210 application number: ANDA205210
Doxazosin	DOXAZOSIN	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	7991373e-8a62-47f9-b4fb-90573485af4e	2024-07-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205210 application number: ANDA205210

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
86P6PQK0MU	DOXAZOSIN MESYLATE	77883-43-3	DOXAZOSIN MESYLATE
NW1291F1W8	DOXAZOSIN	74191-85-8	Doxazosin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-8055-0	50090805500	30 TABLET in 1 BOTTLE (50090-8055-0)	30 tablet	2026-09-14	No	No	Current
50090-8055-1	50090805501	100 TABLET in 1 BOTTLE (50090-8055-1)	100 tablet	2026-09-14	No	No	Current
50090-8055-2	50090805502	90 TABLET in 1 BOTTLE (50090-8055-2)	90 tablet	2026-09-14	No	No	Current