Home NDC 43353-648 Doxazosin
Product NDC 43353-648
11-digit product format 433530648
Labeler code 43353
Product ID 43353-648_094bc311-4e4d-4a6e-9f7b-6015e38af182
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxazosin mesylate
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075509
Marketing category ANDA
Marketing start 2000-10-20
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 2019-12-31
Current FDA listing Historical FDA.report record 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 · 42 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 43353-648-60 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 43353-648-60 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 43353-648-60 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 43353-648-60 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 43353-648-60 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 43353-648-60 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 43353-648-60 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 43353-648-60 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 43353-648-60 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 43353-648-60 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 43353-648-60 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 43353-648-60 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43353-648-60 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43353-648-60 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43353-648-60 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 43353-648-60 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 43353-648-60 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 43353-648-60 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 43353-648-60 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 43353-648-60 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 43353-648-60 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A075509-001 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2000-10-19 A075509-002 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2000-10-19 A075509-003 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2000-10-19 A075509-004 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2000-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 164 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 2026-02-19 14:30 UTC 2026-02 A075509-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2000-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075509-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2000-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075509-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2000-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075509-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2000-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075509-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2000-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075509-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2000-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075509-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2000-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075509-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2000-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075509-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2000-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075509-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2000-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075509-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2000-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075509-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2000-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075509-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2000-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075509-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2000-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075509-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2000-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075509-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2000-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075509-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2000-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075509-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2000-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075509-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2000-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075509-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2000-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075509-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2000-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075509-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2000-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075509-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2000-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075509-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2000-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075509-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2000-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075509-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2000-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075509-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2000-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075509-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2000-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075509-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2000-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075509-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2000-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075509-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2000-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075509-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2000-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075509-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2000-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075509-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2000-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075509-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2000-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075509-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2000-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075509-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2000-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075509-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2000-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075509-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2000-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075509-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2000-10-19 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 92 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-648-60 Doxazosin 90 in 1 BOTTLE, PLASTIC TABLET 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXAZOSIN MESYLATE ACTIVE INGREDIENT 86P6PQK0MU DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 DOXAZOSIN ACTIVE MOIETY NW1291F1W8 DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-648 DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 1 package rows 20140529_be67ff48-8e43-4589-800b-7c67d0c36cea.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 Doxazosin DOXAZOSIN MESYLATE Aurobindo Pharma Limited 93f2d724-5a54-4721-b04a-e46bc764607b 2024-09-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075509 application number: ANDA075509
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-648-60 43353064860 90 in 1 BOTTLE, PLASTIC Historical