Doxazosin

Product NDC: 71610-789
11-digit product format: 716100789
Labeler code: 71610
Product ID: 71610-789_2740bf42-a82a-44fb-9617-a005a5561d64
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxazosin Mesylate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA209013
Marketing category: ANDA
Marketing start: 2018-04-17
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: 2026-12-31
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
A209013-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17
A209013-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17
A209013-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17
A209013-004	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209013-001	AB
A209013-002	AB
A209013-003	AB
A209013-004	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	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`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	A209013-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209013-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209013-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209013-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209013-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209013-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209013-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209013-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209013-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209013-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209013-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209013-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209013-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209013-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209013-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209013-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-004	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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXAZOSIN MESYLATE	4 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
197627	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
0d9df8e9-f823-4ff8-a5fe-0309dd132b04	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	Strength	SPL version
71610-789-60	Doxazosin	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
71610-789-60	EA - Each	71610-789	0412681f-f217-422e-b44d-d0d5c96f06c0	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-789	DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, 1 package rows	20240209_0d9df8e9-f823-4ff8-a5fe-0309dd132b04.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
Doxazosin	DOXAZOSIN MESYLATE	Bryant Ranch Prepack	277c3278-4fe2-47ac-9115-15b417325ffd	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209013 application number: ANDA209013
Doxazosin	DOXAZOSIN MESYLATE	Northwind Health Company, LLC	f6c9856e-9154-f349-e053-6294a90a9f2c	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209013 application number: ANDA209013
Doxazosin	DOXAZOSIN MESYLATE	Upsher-Smith laboratories, LLC	b5d1c604-ce3b-4973-845f-9db267a945cd	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209013 application number: ANDA209013
Doxazosin	DOXAZOSIN MESYLATE	A-S Medication Solutions	b4c974ad-cbd6-4811-ab48-461e7ffa99f7	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209013 application number: ANDA209013
Doxazosin	DOXAZOSIN MESYLATE	Aphena Pharma Solutions - Tennessee, LLC	0d9df8e9-f823-4ff8-a5fe-0309dd132b04	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209013 application number: ANDA209013 ndc (product): 71610-789
Doxazosin	DOXAZOSIN MESYLATE	Aphena Pharma Solutions - Tennessee, LLC	6b74b18f-b89a-4109-a29e-c4fa65a3c5ee	2020-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209013 application number: ANDA209013

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
197627	doxazosin mesylate 4 MG Oral Tablet	PSN	0d9df8e9-f823-4ff8-a5fe-0309dd132b04	1
197627	doxazosin 4 MG Oral Tablet	SCD	0d9df8e9-f823-4ff8-a5fe-0309dd132b04	1
197627	doxazosin (as doxazosin mesylate) 4 MG Oral Tablet	SY	0d9df8e9-f823-4ff8-a5fe-0309dd132b04	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71610-789-60	71610078960	90 TABLET in 1 BOTTLE (71610-789-60)	90 tablet	2024-01-25	No	No	Current