Doxazosin

Product NDC
33261-658
11-digit product format
332610658
Labeler code
33261
Product ID
33261-658_8828c164-2572-4b0e-8228-d86a9ca630d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxazosin mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075509
Marketing category
ANDA
Marketing start
2011-10-27
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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-658IInactivated by FDA2026-08-10
excluded packagepackage33261-65833261-658-30IInactivated by FDA2026-08-10

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-658-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-658-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-658-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-658-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-658-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-658-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-658-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-658-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-658-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-658-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-658-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-658-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-658-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-658-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-658-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-658-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-658-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-658-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-658-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-658-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33261-658-309bebd1f3094a…5416666fcb17…

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
A075509-001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-19
A075509-002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-19
A075509-003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-19
A075509-004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075509-001AB
A075509-002AB
A075509-003AB
A075509-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075509-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075509-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075509-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075509-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075509-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075509-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075509-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075509-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075509-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075509-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075509-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075509-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075509-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075509-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075509-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075509-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075509-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075509-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075509-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075509-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075509-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075509-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075509-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075509-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075509-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075509-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075509-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075509-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075509-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075509-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075509-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075509-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075509-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075509-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075509-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075509-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075509-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A075509-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A075509-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A075509-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-19d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075509-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075509-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075509-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075509-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075509-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075509-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075509-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075509-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075509-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075509-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075509-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075509-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075509-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075509-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075509-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075509-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075509-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075509-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075509-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075509-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075509-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075509-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075509-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075509-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075509-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075509-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075509-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075509-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075509-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075509-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075509-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075509-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075509-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075509-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075509-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075509-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075509-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075509-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075509-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075509-004AB1d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
07a517fc-5845-3816-0f81-0a121804ec9eProduct name620250107
171dd63c-7eea-ede4-c010-4c25ba0a1087Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-658-302020-01-31C16284748780-19d75b9d0-fa72-f424-e053-dadaa90a57ceDOXAZOSIN MESYLATE 4MG TAB FOR MYLAN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-658-30Doxazosin30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-658-30EA - Each33261-6586e3ba905-a88a-456a-a746-8ff90465d86e12015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-658DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 1 package rows20140106_dc9b589b-d6ce-4780-9de4-3d95a30f44ba.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxazosinDOXAZOSIN MESYLATEAurobindo Pharma Limited93f2d724-5a54-4721-b04a-e46bc764607b2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075509
application number: ANDA075509

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197627doxazosin mesylate 4 MG Oral TabletPSNdc9b589b-d6ce-4780-9de4-3d95a30f44ba2
197627doxazosin 4 MG Oral TabletSCDdc9b589b-d6ce-4780-9de4-3d95a30f44ba2
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYdc9b589b-d6ce-4780-9de4-3d95a30f44ba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-658-303326106583030 in 1 BOTTLE, PLASTICHistorical