Home NDC 58657-821-01 Doxazosin
Product NDC 58657-821
Requested package NDC 58657-821-01
11-digit product format 586570821
Labeler code 58657
Product ID 58657-821_eda1b836-6011-bad4-e053-2a95a90a8662
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxazosin
Dosage form TABLET
Route ORAL
Labeler Method Pharmaceuticals, LLC
Application ANDA212727
Marketing category ANDA
Marketing start 2022-06-01
Marketing end 0000-00-00
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 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A212727-001 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 A212727-002 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 A212727-003 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 A212727-004 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15
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 3 · 120 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 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
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 Rising Pharma Holdings, Inc. 508b908e-8d80-422e-8ec0-2081185f4c95 2024-06-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 212727 application number: ANDA212727
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58657-821-01 58657082101 100 TABLET in 1 BOTTLE (58657-821-01) 100 tablet 2022-06-01 0000-00-00 No No Current