Doxazosin mesylate

Product NDC: 71610-120
Requested package NDC: 71610-120-09
11-digit product format: 716100120
Labeler code: 71610
Product ID: 71610-120_d53bcc2c-29da-459a-b82b-b34d3dee074f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxazosin mesylate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA019668
Marketing category: NDA
Marketing start: 2014-07-07
Marketing end: 0000-00-00
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71610-120	71610-120-09	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-120	71610-120-09	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-120	71610-120-09	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 172 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
2026-09-14 22:38:34	2026-08	N019668-001	CARDURA	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	1990-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019668-002	CARDURA	EQ 2MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019668-003	CARDURA	EQ 4MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019668-004	CARDURA	EQ 8MG BASE	TABLET / ORAL	AB	RLD	1990-11-02	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019668-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019668-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019668-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019668-004	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-120-09	EA - Each	71610-120	300f5f82-3d89-4b7c-ba1b-590efb80ca85	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-120	DOXAZOSIN MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20180831_9f3b80cc-cb90-40b5-84d2-24e1c6ffa2ed.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-120-09	71610012009	9000 TABLET in 1 BOTTLE (71610-120-09)	9000 tablet	2018-08-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxazosin mesylate	Aphena Pharma Solutions - Tennessee, LLC	2018-08-27	HUMAN PRESCRIPTION DRUG LABEL	1