Doxazosin

Product NDC: 70518-3965
11-digit product format: 705183965
Labeler code: 70518
Product ID: 70518-3965_3bb3e30f-210c-291c-e063-6294a90a280b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxazosin
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA208719
Marketing category: ANDA
Marketing start: 2023-12-17
Substance: DOXAZOSIN MESYLATE
Active strength: 2 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 42.

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	Approval date
A208719-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07
A208719-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07
A208719-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07
A208719-004	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A208719-001	AB
A208719-002	AB
A208719-003	AB
A208719-004	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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208719-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208719-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208719-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208719-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208719-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208719-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxazosin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXAZOSIN MESYLATE	2 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
197626	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
ec06f008-37a1-4757-a3ee-0b4720912bc4	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
70518-3965-0	Doxazosin	30 in 1 BLISTER PACK	TABLET	30		4
70518-3965-1	Doxazosin	90 in 1 BOTTLE, PLASTIC	TABLET	90		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3965	DOXAZOSIN TABLET [REMEDYREPACK INC.]	3	Current NDC, 2 package rows	20240503_ec06f008-37a1-4757-a3ee-0b4720912bc4.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxazosin	DOXAZOSIN	REMEDYREPACK INC.	ec06f008-37a1-4757-a3ee-0b4720912bc4	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719 ndc (product): 70518-3965
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals, Inc.	30b709d6-c438-c721-e063-6294a90abd61	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals,Inc.	88efdfb0-710f-768a-e053-2995a90aede4	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	Zydus Lifesciences Limited	ac889877-133c-4448-af5a-d77b3cbfe878	2024-11-28		Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	A-S Medication Solutions	46b01b1d-c48a-4c36-bf3c-bba98066166c	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	187bc51b-7a3a-5910-e063-6294a90aa888	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	Bryant Ranch Prepack	6fbb9ca2-e8ca-45c7-a178-b4c8dd7a9a1f	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	Zydus Pharmaceuticals USA Inc.	e4758bf9-b9d4-4268-beb8-0d7e06890895	2023-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719

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
197626	doxazosin mesylate 2 MG Oral Tablet	PSN	ec06f008-37a1-4757-a3ee-0b4720912bc4	4
197626	doxazosin 2 MG Oral Tablet	SCD	ec06f008-37a1-4757-a3ee-0b4720912bc4	4
197626	doxazosin (as doxazosin mesylate) 2 MG Oral Tablet	SY	ec06f008-37a1-4757-a3ee-0b4720912bc4	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3965-0	70518396500	30 TABLET in 1 BLISTER PACK (70518-3965-0)	30 tablet	2023-12-17	No	No	Current
70518-3965-1	70518396501	90 TABLET in 1 BOTTLE, PLASTIC (70518-3965-1)	90 tablet	2024-05-01	No	No	Current