Doxazosin Mesylate

Product NDC
53747-352
11-digit product format
537470352
Labeler code
53747
Product ID
53747-352_761d3af7-ac26-462c-a5a0-0435f782bd62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Laboratories Limited, India
Application
ANDA212329
Marketing category
ANDA
Marketing start
2024-01-10
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 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212329-001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2024-01-10
A212329-002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2024-01-10
A212329-003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2024-01-10
A212329-004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2024-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212329-001AB
A212329-002AB
A212329-003AB
A212329-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212329-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2024-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212329-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2024-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212329-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2024-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212329-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2024-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212329-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2024-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212329-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2024-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212329-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2024-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212329-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2024-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212329-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2024-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212329-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2024-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212329-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2024-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212329-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2024-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212329-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2024-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212329-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2024-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212329-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2024-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212329-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2024-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212329-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2024-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212329-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2024-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212329-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2024-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212329-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2024-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212329-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2024-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212329-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2024-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212329-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2024-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212329-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2024-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212329-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2024-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212329-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2024-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212329-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2024-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212329-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2024-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212329-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2024-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212329-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2024-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212329-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2024-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212329-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2024-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212329-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2024-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212329-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2024-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212329-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2024-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212329-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2024-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212329-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2024-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A212329-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2024-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A212329-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2024-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A212329-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2024-01-10d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212329-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212329-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212329-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212329-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212329-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212329-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212329-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212329-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212329-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212329-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212329-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212329-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212329-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212329-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212329-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212329-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212329-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212329-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212329-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212329-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212329-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212329-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212329-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212329-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212329-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212329-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212329-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212329-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212329-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212329-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212329-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212329-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212329-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212329-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212329-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212329-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212329-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212329-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212329-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212329-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Doxazosin Mesylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE2 mg/1

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxazosin MesylateDOXAZOSIN MESYLATEUnichem Pharmaceuticals (USA), Inc.44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f2024-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212329
application number: ANDA212329

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53747-352-0153747035201100 TABLET in 1 BOTTLE (53747-352-01) 100 tablet2024-03-15NoNoCurrent
53747-352-10537470352101000 TABLET in 1 BOTTLE (53747-352-10) 1000 tablet2024-03-15NoNoCurrent
53747-352-135374703521330 TABLET in 1 BOTTLE (53747-352-13) 30 tablet2024-03-15NoNoCurrent