Doxazosin

Product NDC: 51655-109
11-digit product format: 516550109
Labeler code: 51655
Product ID: 51655-109_48c3b853-1eef-73bd-e063-6294a90a9355
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxazosin
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA202824
Marketing category: ANDA
Marketing start: 2022-08-19
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 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
A202824-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2014-06-11
A202824-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2014-06-11
A202824-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2014-06-11
A202824-004	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2014-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202824-001	AB
A202824-002	AB
A202824-003	AB
A202824-004	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	A202824-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202824-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202824-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202824-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2014-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202824-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202824-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202824-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202824-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202824-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202824-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202824-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202824-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202824-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202824-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202824-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202824-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202824-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202824-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202824-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202824-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202824-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2014-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202824-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2014-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202824-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2014-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202824-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2014-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202824-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202824-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202824-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202824-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202824-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202824-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202824-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202824-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202824-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2014-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202824-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2014-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202824-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2014-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202824-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2014-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202824-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2014-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202824-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2014-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202824-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2014-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202824-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2014-06-11	`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	A202824-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202824-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202824-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202824-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202824-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202824-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202824-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202824-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202824-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202824-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202824-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202824-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202824-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202824-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202824-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202824-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202824-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202824-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202824-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202824-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202824-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202824-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202824-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202824-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202824-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202824-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202824-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202824-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202824-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202824-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202824-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202824-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202824-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202824-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202824-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202824-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202824-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202824-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202824-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202824-004	AB	1	`d06236e962d9…`

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

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
f2b35586-d550-3fcb-e053-2995a90a3403	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
51655-109-52	Doxazosin	30 in 1 BOTTLE, PLASTIC	TABLET	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-109	DOXAZOSIN TABLET [NORTHWIND PHARMACEUTICALS, LLC]	4	Current NDC, 1 package rows	20241215_f2b35586-d550-3fcb-e053-2995a90a3403.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxazosin	DOXAZOSIN	REMEDYREPACK INC.	71815e8f-33ed-4f36-a8ec-d4443151a9d8	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824
Doxazosin	DOXAZOSIN	Northwind Health Company, LLC	f2b35586-d550-3fcb-e053-2995a90a3403	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824 ndc (product): 51655-109
DOXAZOSIN	DOXAZOSIN	direct rx	b57cf33b-e0bd-54e9-e053-2a95a90a5a6a	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824
Doxazosin	DOXAZOSIN	Bryant Ranch Prepack	8c0c0345-833b-4a3d-9081-da66b208d750	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824
Doxazosin	DOXAZOSIN	Bryant Ranch Prepack	ef8b5534-5939-400a-ad5e-f9ceaefc4097	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824
Doxazosin	DOXAZOSIN	Bryant Ranch Prepack	ac4cd22b-2a03-47b6-9eed-550be278f17d	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824
Doxazosin	DOXAZOSIN	Accord Healthcare Inc.	2830533c-ccdf-4401-b19c-763eeb1bc0a7	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals, Inc.	40e47e75-6a47-323b-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824
Doxazosin	DOXAZOSIN	A-S Medication Solutions	4034fb6d-f55d-4df0-b500-d6a413591f6e	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824
Doxazosin	DOXAZOSIN	A-S Medication Solutions	9f67fa58-f623-4145-9e2c-98feee7ca45f	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals,Inc.	64a243e6-7056-115d-e053-2a91aa0a510f	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals,Inc.	64a19cb1-79fc-8b0b-e053-2a91aa0aaa94	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824
Doxazosin	DOXAZOSIN	Proficient Rx LP	8de7d5ee-7f9d-447a-af76-7a7fbf3eb33d	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202824 application number: ANDA202824

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
197627	doxazosin mesylate 4 MG Oral Tablet	PSN	f2b35586-d550-3fcb-e053-2995a90a3403	5
197627	doxazosin 4 MG Oral Tablet	SCD	f2b35586-d550-3fcb-e053-2995a90a3403	5
197627	doxazosin (as doxazosin mesylate) 4 MG Oral Tablet	SY	f2b35586-d550-3fcb-e053-2995a90a3403	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-109-52	51655010952	30 TABLET in 1 BOTTLE, PLASTIC (51655-109-52)	30 tablet	2022-08-19	No	No	Current