Doxazosin

Product NDC
51079-958
11-digit product format
510790958
Labeler code
51079
Product ID
51079-958_a59f8fda-67cb-d3bd-e053-2995a90a00e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxazosin mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA075509
Marketing category
ANDA
Marketing start
2001-01-01
Marketing end
2021-04-30
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
0000-00-00
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 productproduct51079-958DDiscontinued by firm2026-08-11
excluded packagepackage51079-95851079-958-20DDiscontinued by firm2026-08-11

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 · 24 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 packagepackage51079-958-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51079-958-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51079-958-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51079-958-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51079-958-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51079-958-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51079-958-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51079-958-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51079-958-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51079-958-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51079-958-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51079-958-20557ba5c1ecfa…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-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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-958-01EA - Each51079-9583d68f513-9584-42b9-b7ed-2f713c045ca512012-07-24
51079-958-20EA - Each51079-95883365f26-e014-4e68-b30b-cf666632e78312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN TABLET [CARDINAL HEALTH]8
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN TABLET [CARDINAL HEALTH]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDOXAZOSIN TABLET [CARDINAL HEALTH]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN TABLET [CARDINAL HEALTH]8
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDOXAZOSIN TABLET [CARDINAL HEALTH]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXAZOSIN TABLET [CARDINAL HEALTH]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN TABLET [CARDINAL HEALTH]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXAZOSIN TABLET [CARDINAL HEALTH]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXAZOSIN TABLET [CARDINAL HEALTH]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXAZOSIN TABLET [CARDINAL HEALTH]8
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [MYLAN INSTITUTIONAL INC.]6
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [MYLAN INSTITUTIONAL INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [MYLAN INSTITUTIONAL INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [MYLAN INSTITUTIONAL INC.]6
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [MYLAN INSTITUTIONAL INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [MYLAN INSTITUTIONAL INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [MYLAN INSTITUTIONAL INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [MYLAN INSTITUTIONAL INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [MYLAN INSTITUTIONAL INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [MYLAN INSTITUTIONAL INC.]6

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-958-2051079095820100 BLISTER PACK in 1 CARTON (51079-958-20) > 1 TABLET in 1 BLISTER PACK (51079-958-01) 100 blister pack2001-01-012021-04-30NoNoCurrent