Doxazosin

Product NDC
84677-044
11-digit product format
846770044
Labeler code
84677
Product ID
84677-044_54eef6fc-7426-43e3-e063-6294a90a55d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA205210
Marketing category
ANDA
Marketing start
2018-02-13
Substance
DOXAZOSIN MESYLATE
Active strength
1 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A205210-001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-13
A205210-002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-13
A205210-003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-13
A205210-004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205210-001AB
A205210-002AB
A205210-003AB
A205210-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205210-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-1384e616aacf4f…
2026-09-14 22:38:342026-08A205210-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-1384e616aacf4f…
2026-09-14 22:38:342026-08A205210-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-1384e616aacf4f…
2026-09-14 22:38:342026-08A205210-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-1384e616aacf4f…
2026-08-18 06:07:402026-07A205210-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A205210-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A205210-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A205210-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205210-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205210-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205210-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205210-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205210-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205210-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205210-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205210-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A205210-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205210-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205210-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205210-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205210-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205210-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205210-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205210-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205210-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205210-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205210-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205210-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205210-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205210-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205210-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205210-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205210-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205210-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205210-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205210-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205210-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205210-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205210-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205210-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-135bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205210-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A205210-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A205210-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A205210-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A205210-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205210-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205210-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205210-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205210-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205210-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205210-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205210-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205210-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205210-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205210-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205210-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205210-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205210-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205210-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205210-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205210-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205210-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205210-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205210-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205210-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205210-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205210-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205210-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205210-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205210-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205210-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205210-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205210-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205210-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205210-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205210-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205210-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205210-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205210-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205210-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Doxazosin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86P6PQK0MUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197625Internal RxNorm lookup
197626Internal RxNorm lookup
197627Internal RxNorm lookup
197628Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
54eeef3d-c906-37e7-e063-6294a90afca2Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxazosinDOXAZOSINGolden State Medical Supply, Inc.54eeef3d-c906-37e7-e063-6294a90afca22026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205210
application number: ANDA205210
ndc (product): 84677-044
DoxazosinDOXAZOSINHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.7991373e-8a62-47f9-b4fb-90573485af4e2024-07-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205210
application number: ANDA205210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84677-044-0184677004401100 TABLET in 1 BOTTLE (84677-044-01) 100 tablet2026-05-11NoNoCurrent