Cardura

Product NDC: 0049-2720
11-digit product format: 000492720
Labeler code: 0049
Product ID: 0049-2720_36e114e8-4a87-4dfd-988c-4d2362ac06bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxazosin mesylate
Dosage form: TABLET, MULTILAYER, EXTENDED RELEASE
Route: ORAL
Labeler: Roerig
Application: NDA021269
Marketing category: NDA
Marketing start: 2005-02-22
Marketing end: 0000-00-00
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0049-2720		D	Discontinued by firm		2026-08-10
excluded package	package	0049-2720	0049-2720-30	D	Discontinued by firm		2026-08-10

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0049-2720-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0049-2720-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0049-2720-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0049-2720-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0049-2720-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0049-2720-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0049-2720-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0049-2720-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0049-2720-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0049-2720-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0049-2720-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0049-2720-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021269-001	CARDURA XL	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-02-22
N021269-002	CARDURA XL	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2005-02-22

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0049-2720-30	EA - Each	0049-2720	9c384aeb-a146-4f11-bd63-e608092679ed	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXAZOSIN MESYLATE	ACTIVE INGREDIENT	86P6PQK0MU	CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]	9
DOXAZOSIN	ACTIVE MOIETY	NW1291F1W8	CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]	9
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]	9
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]	9
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]	9

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cardura XL	DOXAZOSIN MESYLATE	Viatris Specialty LLC	355bcdce-0481-48ba-8ebd-2009106aaf77	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021269 application number: NDA021269

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0049-2720-30	00049272030	30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0049-2720-30)	2005-02-22	0000-00-00	No	No	Current