Cardura

Product NDC: 0049-2040
Requested package NDC: 0049-2040-10
11-digit product format: 000492040
Labeler code: 0049
Product ID: 0049-2040_36e114e8-4a87-4dfd-988c-4d2362ac06bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxazosin
Dosage form: TABLET, MULTILAYER, EXTENDED RELEASE
Route: ORAL
Labeler: Roerig
Application: NDA021269
Marketing category: NDA
Marketing start: 2021-01-21
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	0049-2040	0049-2040-10	D	Discontinued by firm		2026-08-03

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…`

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 · 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0049-2040-10	EA - Each	0049-2040	60dc10fe-5471-44df-a3b7-afdb43082636	1	2022-03-09

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0049-2040-10	00049204010	30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0049-2040-10)	2021-01-21	0000-00-00	No	No	Current