Doxazosin

Product NDC: 71610-160
11-digit product format: 716100160
Labeler code: 71610
Product ID: 71610-160_c783db8d-05dc-4b11-9f6a-bcb821b73cac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxazosin
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075580
Marketing category: ANDA
Marketing start: 2015-04-09
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
A075580-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18
A075580-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18
A075580-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18
A075580-004	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
A075580-001	AB
A075580-002	AB
A075580-003	AB
A075580-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A075580-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075580-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075580-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075580-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A075580-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075580-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075580-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075580-004	AB	1	`a50c72e98297…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxazosin	DOXAZOSIN	A-S Medication Solutions	bfea0b5b-9354-490f-88ff-008134077d24	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	REMEDYREPACK INC.	bf2f7b41-f14d-4fcd-8db3-f507ca6ff78b	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	PD-Rx Pharmaceuticals, Inc.	2ea9bb6b-a4f0-496a-b27b-4454167a4b70	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Cardinal Health 107, LLC	08521333-ff21-45ad-b99e-1f43d945d24d	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	REMEDYREPACK INC.	30a6bb83-f91b-4c4f-a849-4f2be3735a0e	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Preferred Pharmaceuticals Inc.	2110eec5-949d-4718-ad6d-3629e5db8a07	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Preferred Pharmaceuticals Inc.	e046e0b7-f510-4318-9884-034d683864d4	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	AvPAK	de9ab9a4-d8b8-8b36-e053-2a95a90aaa35	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	AvKARE	e3d381c1-3b2f-af70-f4e6-08d6202eed25	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals, Inc.	54116886-ea5e-5320-e054-00144ff8d46c	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Bryant Ranch Prepack	54549d19-6311-4dbb-8622-fd3e5440551a	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Northwind Health Company, LLC	f306adae-a2fe-5477-e053-2995a90a7838	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	American Health Packaging	3f4dc1a7-05e6-41d7-908c-30ce2677d87b	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Apotex Corp.	4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Major Pharmaceuticals	3354196f-bbcf-4bc5-94f6-e6e8e132acb1	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	2e5cd8cb-7d43-e7af-e063-6294a90a310e	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals, Inc.	505d3c4c-5506-72cc-e054-00144ff88e88	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Proficient Rx LP	1d8ff659-8129-4dca-9e8f-13b97240d1e1	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	f1dc70f6-4329-46da-8990-7bd6eec9d37d	2021-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580 ndc (product): 71610-160
Doxazosin	DOXAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	7e547752-a53a-4ad9-b70e-7cc2a1dd5d5d	2018-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197626	Internal RxNorm lookup
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
f1dc70f6-4329-46da-8990-7bd6eec9d37d	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
71610-160-16	Doxazosin	6000 in 1 BOTTLE	TABLET	6000		2
71610-160-60	Doxazosin	90 in 1 BOTTLE	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-160-16	EA - Each	71610-160	dc56e12d-3803-491c-a7cd-5d60ef651ea3	1	2018-12-13
71610-160-60	EA - Each	71610-160	ee85c29f-e867-4607-ae64-8b4155043dd0	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-160	DOXAZOSIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20211209_f1dc70f6-4329-46da-8990-7bd6eec9d37d.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
197626	doxazosin mesylate 2 MG Oral Tablet	PSN	f1dc70f6-4329-46da-8990-7bd6eec9d37d	2
197628	doxazosin mesylate 8 MG Oral Tablet	PSN	f1dc70f6-4329-46da-8990-7bd6eec9d37d	2
197626	doxazosin 2 MG Oral Tablet	SCD	f1dc70f6-4329-46da-8990-7bd6eec9d37d	2
197628	doxazosin 8 MG Oral Tablet	SCD	f1dc70f6-4329-46da-8990-7bd6eec9d37d	2
197626	doxazosin (as doxazosin mesylate) 2 MG Oral Tablet	SY	f1dc70f6-4329-46da-8990-7bd6eec9d37d	2
197628	doxazosin (as doxazosin mesylate) 8 MG Oral Tablet	SY	f1dc70f6-4329-46da-8990-7bd6eec9d37d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-160-16	71610016016	6000 TABLET in 1 BOTTLE (71610-160-16)	6000 tablet	2018-09-20	0000-00-00	No	No	Current
71610-160-60	71610016060	90 TABLET in 1 BOTTLE (71610-160-60)	90 tablet	2021-11-23	0000-00-00	No	No	Current