Cardura

Product NDC: 58151-079
11-digit product format: 581510079
Labeler code: 58151
Product ID: 58151-079_7fe31b0a-4fb2-427f-83e2-d5b957d6738b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxazosin mesylate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Viatris Specialty LLC
Application: NDA021269
Marketing category: NDA
Marketing start: 2024-01-04
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cardura
Brand name suffix: XL
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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
636360	Internal RxNorm lookup
636361	Internal RxNorm lookup
1242404	Internal RxNorm lookup
1242408	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
355bcdce-0481-48ba-8ebd-2009106aaf77	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
58151-079-93	CarduraXL	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58151-079-93	EA - Each	58151-079	5da49b53-8255-4480-b2fc-6506d9b7727c	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58151-079	CARDURA XL (DOXAZOSIN MESYLATE) TABLET, FILM COATED, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]	2	Current NDC, 1 package rows	20240425_355bcdce-0481-48ba-8ebd-2009106aaf77.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 · 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 ndc (product): 58151-079

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
86P6PQK0MU	DOXAZOSIN MESYLATE	77883-43-3	DOXAZOSIN MESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1242404	Cardura XL 4 MG 24HR Extended Release Oral Tablet	PSN	355bcdce-0481-48ba-8ebd-2009106aaf77	2
1242408	Cardura XL 8 MG 24HR Extended Release Oral Tablet	PSN	355bcdce-0481-48ba-8ebd-2009106aaf77	2
636360	doxazosin mesylate 4 MG 24HR Extended Release Oral Tablet	PSN	355bcdce-0481-48ba-8ebd-2009106aaf77	2
636361	doxazosin mesylate 8 MG 24HR Extended Release Oral Tablet	PSN	355bcdce-0481-48ba-8ebd-2009106aaf77	2
1242404	24 HR doxazosin 4 MG Extended Release Oral Tablet [Cardura]	SBD	355bcdce-0481-48ba-8ebd-2009106aaf77	2
1242408	24 HR doxazosin 8 MG Extended Release Oral Tablet [Cardura]	SBD	355bcdce-0481-48ba-8ebd-2009106aaf77	2
636360	24 HR doxazosin 4 MG Extended Release Oral Tablet	SCD	355bcdce-0481-48ba-8ebd-2009106aaf77	2
636361	24 HR doxazosin 8 MG Extended Release Oral Tablet	SCD	355bcdce-0481-48ba-8ebd-2009106aaf77	2
1242404	24 HR Cardura 4 MG Extended Release Oral Tablet	SY	355bcdce-0481-48ba-8ebd-2009106aaf77	2
1242408	24 HR Cardura 8 MG Extended Release Oral Tablet	SY	355bcdce-0481-48ba-8ebd-2009106aaf77	2
1242404	Cardura XL 4 MG (as doxazosin mesylate 5.1 MG) 24 HR Extended Release Oral Tablet	SY	355bcdce-0481-48ba-8ebd-2009106aaf77	2
1242404	Cardura XL 4 MG 24 HR Extended Release Oral Tablet	SY	355bcdce-0481-48ba-8ebd-2009106aaf77	2
1242408	Cardura XL 8 MG (as doxazosin mesylate 10.2 MG) 24 HR Extended Release Oral Tablet	SY	355bcdce-0481-48ba-8ebd-2009106aaf77	2
1242408	Cardura XL 8 MG 24 HR Extended Release Oral Tablet	SY	355bcdce-0481-48ba-8ebd-2009106aaf77	2
636360	doxazosin (as doxazosin mesylate) 4 MG 24 HR Extended Release Oral Tablet	SY	355bcdce-0481-48ba-8ebd-2009106aaf77	2
636361	doxazosin (as doxazosin mesylate) 8 MG 24 HR Extended Release Oral Tablet	SY	355bcdce-0481-48ba-8ebd-2009106aaf77	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
58151-079-93	58151007993	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-079-93)	2024-01-04	No	No	Current