Home NDC 29300-354 Doxazosin Mesylate
Product NDC 29300-354
11-digit product format 293000354
Labeler code 29300
Product ID 29300-354_e2406e8e-68c2-49dc-9e15-6170f3fffa03
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxazosin Mesylate
Dosage form TABLET
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA212329
Marketing category ANDA
Marketing start 2024-01-10
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212329-001 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-01-10 A212329-002 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2024-01-10 A212329-003 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2024-01-10 A212329-004 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2024-01-10
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 2 · 68 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 A212329-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212329-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2024-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212329-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2024-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212329-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2024-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212329-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212329-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2024-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212329-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2024-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212329-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2024-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212329-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212329-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2024-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212329-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2024-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212329-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2024-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212329-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212329-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2024-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212329-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2024-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212329-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2024-01-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212329-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-01-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212329-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2024-01-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212329-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2024-01-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212329-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2024-01-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212329-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-01-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212329-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2024-01-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212329-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2024-01-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212329-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2024-01-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212329-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-01-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212329-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2024-01-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212329-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2024-01-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212329-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2024-01-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212329-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-01-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212329-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2024-01-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212329-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2024-01-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212329-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2024-01-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212329-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-01-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212329-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2024-01-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212329-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2024-01-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212329-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2024-01-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212329-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-01-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212329-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2024-01-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212329-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2024-01-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212329-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2024-01-10 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Doxazosin Mesylate
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 197625 Internal RxNorm lookup 197626 Internal RxNorm lookup 197627 Internal RxNorm lookup 197628 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 29300-354-01 Doxazosin Mesylate 100 in 1 BOTTLE TABLET 100 4 29300-354-10 Doxazosin Mesylate 1000 in 1 BOTTLE TABLET 1000 4 29300-354-13 Doxazosin Mesylate 30 in 1 BOTTLE TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29300-354 DOXAZOSIN MESYLATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] 4 Current NDC, 3 package rows 20240124_44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 29300-354-01 29300035401 100 TABLET in 1 BOTTLE (29300-354-01) 100 tablet 2024-03-15 No No Current 29300-354-10 29300035410 1000 TABLET in 1 BOTTLE (29300-354-10) 1000 tablet 2024-03-15 No No Current 29300-354-13 29300035413 30 TABLET in 1 BOTTLE (29300-354-13) 30 tablet 2024-03-15 No No Current