Doxazosin

Product NDC: 71610-831
11-digit product format: 716100831
Labeler code: 71610
Product ID: 71610-831_187bc466-9b63-4ac5-e063-6294a90a7e9b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxazosin
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA208719
Marketing category: ANDA
Marketing start: 2017-08-31
Substance: DOXAZOSIN MESYLATE
Active strength: 8 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 1.

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
A208719-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07
A208719-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07
A208719-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07
A208719-004	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208719-001	AB
A208719-002	AB
A208719-003	AB
A208719-004	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 · 164 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	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A208719-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208719-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208719-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208719-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208719-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208719-004	AB	1	`d06236e962d9…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxazosin	DOXAZOSIN	REMEDYREPACK INC.	ec06f008-37a1-4757-a3ee-0b4720912bc4	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals, Inc.	30b709d6-c438-c721-e063-6294a90abd61	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals,Inc.	88efdfb0-710f-768a-e053-2995a90aede4	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	Zydus Lifesciences Limited	ac889877-133c-4448-af5a-d77b3cbfe878	2024-11-28		Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	A-S Medication Solutions	46b01b1d-c48a-4c36-bf3c-bba98066166c	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	187bc51b-7a3a-5910-e063-6294a90aa888	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719 ndc (product): 71610-831
Doxazosin	DOXAZOSIN	Bryant Ranch Prepack	6fbb9ca2-e8ca-45c7-a178-b4c8dd7a9a1f	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	Zydus Pharmaceuticals USA Inc.	e4758bf9-b9d4-4268-beb8-0d7e06890895	2023-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719

Additional Listing Data#

Finished product: Yes
Brand name base: Doxazosin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXAZOSIN MESYLATE	8 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
197628	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
187bc51b-7a3a-5910-e063-6294a90aa888	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
71610-831-53	Doxazosin	60 in 1 BOTTLE	TABLET	60		1
71610-831-60	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
71610-831-53	EA - Each	71610-831	8178af99-c3b8-4d43-818c-799a86ceaff6	1	2024-07-12
71610-831-60	EA - Each	71610-831	1126ab59-fa90-4638-83ac-a5b1fd04052c	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-831	DOXAZOSIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]	1	Current NDC, 2 package rows	20240517_187bc51b-7a3a-5910-e063-6294a90aa888.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197628	doxazosin mesylate 8 MG Oral Tablet	PSN	187bc51b-7a3a-5910-e063-6294a90aa888	1
197628	doxazosin 8 MG Oral Tablet	SCD	187bc51b-7a3a-5910-e063-6294a90aa888	1
197628	doxazosin (as doxazosin mesylate) 8 MG Oral Tablet	SY	187bc51b-7a3a-5910-e063-6294a90aa888	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71610-831-53	71610083153	60 TABLET in 1 BOTTLE (71610-831-53)	60 tablet	2024-05-13	No	No	Current
71610-831-60	71610083160	90 TABLET in 1 BOTTLE (71610-831-60)	90 tablet	2024-05-13	No	No	Current