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 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	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 · 164 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
2026-02-19 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…`
2024-10-29 15:01 UTC	2024-10	N019668-001	CARDURA	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019668-002	CARDURA	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019668-003	CARDURA	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019668-004	CARDURA	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`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	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…`
2024-10-29 15:01 UTC	2024-10	N019668-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019668-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019668-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019668-004	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 · 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

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

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