Doxazosin

Product NDC: 71610-628
11-digit product format: 716100628
Labeler code: 71610
Product ID: 71610-628_ac6242cd-cdb3-48a7-915f-c635e71807cd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxazosin
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA019668
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2021-10-19
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 42.

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	RLD / RS	Approval date
N019668-001	CARDURA	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02
N019668-002	CARDURA	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02
N019668-003	CARDURA	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02
N019668-004	CARDURA	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019668-001	AB
N019668-002	AB
N019668-003	AB
N019668-004	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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019668-001	CARDURA	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019668-002	CARDURA	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019668-003	CARDURA	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019668-004	CARDURA	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019668-001	CARDURA	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019668-002	CARDURA	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019668-003	CARDURA	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019668-004	CARDURA	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019668-001	CARDURA	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019668-002	CARDURA	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019668-003	CARDURA	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019668-004	CARDURA	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019668-001	CARDURA	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019668-002	CARDURA	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019668-003	CARDURA	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019668-004	CARDURA	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019668-001	CARDURA	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019668-002	CARDURA	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019668-003	CARDURA	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019668-004	CARDURA	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019668-001	CARDURA	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019668-002	CARDURA	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019668-003	CARDURA	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019668-004	CARDURA	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019668-001	CARDURA	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019668-002	CARDURA	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019668-003	CARDURA	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019668-004	CARDURA	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019668-001	CARDURA	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019668-002	CARDURA	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019668-003	CARDURA	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019668-004	CARDURA	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019668-001	CARDURA	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019668-002	CARDURA	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019668-003	CARDURA	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019668-004	CARDURA	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019668-001	CARDURA	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019668-002	CARDURA	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019668-003	CARDURA	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019668-004	CARDURA	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019668-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019668-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019668-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019668-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019668-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019668-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019668-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019668-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019668-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019668-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019668-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019668-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019668-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019668-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019668-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019668-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019668-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019668-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019668-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019668-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019668-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019668-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019668-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019668-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019668-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019668-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019668-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019668-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019668-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019668-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019668-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019668-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019668-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019668-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019668-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019668-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019668-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019668-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019668-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019668-004	AB	1	`d8e5a09893c0…`

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
b364c7a8-72b5-4776-a500-400c37a72c9b	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
71610-628-60	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
71610-628-60	EA - Each	71610-628	8381f94a-ba5d-466c-afca-e610e32f93f7	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-628	DOXAZOSIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20220208_b364c7a8-72b5-4776-a500-400c37a72c9b.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxazosin mesylate	DOXAZOSIN MESYLATE	Aphena Pharma Solutions - Tennessee, LLC	445dc831-1960-4b25-e063-6294a90a6efd	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019668 application number: NDA019668
Doxazosin	DOXAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	3ab222b7-74cc-5343-e063-6294a90a9616	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019668 application number: NDA019668
Doxazosin mesylate	DOXAZOSIN MESYLATE	Mylan Pharmaceuticals Inc.	2e524986-7903-416f-b2b8-d27295103e75	2024-03-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019668 application number: NDA019668
Cardura	DOXAZOSIN	Viatris Specialty LLC	5e1f5e49-2da1-43ab-9795-228a8bcc5a82	2023-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019668 application number: NDA019668
Doxazosin	DOXAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	b364c7a8-72b5-4776-a500-400c37a72c9b	2022-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019668 application number: NDA019668 ndc (product): 71610-628
Doxazosin	DOXAZOSIN	Mylan Pharmaceuticals Inc.	6b887aa5-5edf-48c5-a480-dea8c35afa9d	2022-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019668 application number: NDA019668
Cardura	DOXAZOSIN	ROERIG	eefc47bc-c10f-49bb-8ef7-5999f798ab39	2022-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019668 application number: NDA019668

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	b364c7a8-72b5-4776-a500-400c37a72c9b	2
197628	doxazosin 8 MG Oral Tablet	SCD	b364c7a8-72b5-4776-a500-400c37a72c9b	2
197628	doxazosin (as doxazosin mesylate) 8 MG Oral Tablet	SY	b364c7a8-72b5-4776-a500-400c37a72c9b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-628-60	71610062860	90 TABLET in 1 BOTTLE (71610-628-60)	90 tablet	2021-12-13	0000-00-00	No	No	Current