Doxazosin

Product NDC: 71335-3081
Requested package NDC: 71335-3081-5
11-digit product format: 713353081
Labeler code: 71335
Product ID: 71335-3081_0070fa6a-c4ec-4f86-aedf-73e956c00d58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxazosin Mesylate
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075536
Marketing category: ANDA
Marketing start: 2014-08-06
Substance: DOXAZOSIN MESYLATE
Active strength: 2 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
A075536-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18
A075536-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18
A075536-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18
A075536-004	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075536-001	AB
A075536-002	AB
A075536-003	AB
A075536-004	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	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`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	A075536-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075536-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075536-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075536-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075536-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075536-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075536-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075536-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075536-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075536-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075536-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075536-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075536-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075536-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075536-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075536-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075536-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075536-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075536-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075536-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075536-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075536-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075536-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075536-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075536-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075536-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075536-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075536-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075536-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075536-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075536-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075536-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075536-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075536-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075536-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075536-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075536-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075536-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075536-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075536-004	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	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
86P6PQK0MU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197626	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
8641cdb1-dc16-4a13-8a84-bc8f6d58b4d4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
07a517fc-5845-3816-0f81-0a121804ec9e	Product name	6	20250107
171dd63c-7eea-ede4-c010-4c25ba0a1087	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-3081-1	Doxazosin	30 in 1 BOTTLE	TABLET	30	1
71335-3081-2	Doxazosin	60 in 1 BOTTLE	TABLET	60	1
71335-3081-3	Doxazosin	90 in 1 BOTTLE	TABLET	90	1
71335-3081-4	Doxazosin	28 in 1 BOTTLE	TABLET	28	1
71335-3081-5	Doxazosin	18 in 1 BOTTLE	TABLET	18	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxazosin	DOXAZOSIN MESYLATE	Bryant Ranch Prepack	e2f5d7d2-21aa-4921-8035-da945d3c565c	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536
Doxazosin	DOXAZOSIN MESYLATE	Bryant Ranch Prepack	8641cdb1-dc16-4a13-8a84-bc8f6d58b4d4	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536 ndc (package): 71335-3081-5 ndc (product): 71335-3081 ndc11 (package): 71335308105
Doxazosin	DOXAZOSIN MESYLATE	A-S Medication Solutions	7aeaa0e1-136c-444d-b66c-7a5a96fb3022	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536
Doxazosin	DOXAZOSIN MESYLATE	Bryant Ranch Prepack	d42d2691-f25d-4dfc-99d0-3286d71480a4	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536
Doxazosin	DOXAZOSIN MESYLATE	A-S Medication Solutions	57f4a953-ad23-4a44-9956-c48aa5927132	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536
Doxazosin	DOXAZOSIN MESYLATE	A-S Medication Solutions	9b6170e7-814a-46ef-b068-cf3e6508d5e1	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536
Doxazosin	DOXAZOSIN MESYLATE	Teva Pharmaceuticals USA, Inc.	0aaa68a7-f73b-46d8-860f-a76d96897489	2021-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
86P6PQK0MU	DOXAZOSIN MESYLATE	77883-43-3	DOXAZOSIN MESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197626	doxazosin mesylate 2 MG Oral Tablet	PSN	8641cdb1-dc16-4a13-8a84-bc8f6d58b4d4	1
197626	doxazosin 2 MG Oral Tablet	SCD	8641cdb1-dc16-4a13-8a84-bc8f6d58b4d4	1
197626	doxazosin (as doxazosin mesylate) 2 MG Oral Tablet	SY	8641cdb1-dc16-4a13-8a84-bc8f6d58b4d4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-3081-5	71335308105	18 TABLET in 1 BOTTLE (71335-3081-5)	18 tablet	2026-02-13	No	No	Current