Home NDC 55289-600-30 Doxazosin
Product NDC 55289-600
Requested package NDC 55289-600-30
11-digit product format 552890600
Labeler code 55289
Product ID 55289-600_a46ee848-84b9-29cd-e053-2a95a90a5ef1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxazosin mesylate
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
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 2021-12-31
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 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXAZOSIN MESYLATE ACTIVE INGREDIENT 86P6PQK0MU DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.] 5 DOXAZOSIN ACTIVE MOIETY NW1291F1W8 DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.] 5 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.] 5
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-600-30 55289060030 30 TABLET in 1 BOTTLE, PLASTIC (55289-600-30) 30 tablet 2011-04-20 0000-00-00 No No Current