Doxazosin Mesylate

Product NDC
67253-380
Requested package NDC
67253-380-10
11-digit product format
672530380
Labeler code
67253
Product ID
67253-380_2a486bcb-1296-455e-8b3c-78bf5b217936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA076161
Marketing category
ANDA
Marketing start
2004-06-10
Marketing end
2021-02-28
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67253-38067253-380-10DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
A076161-001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2004-06-10
A076161-002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2004-06-10
A076161-003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2004-06-10
A076161-004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2004-06-10

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 UTC2026-02A076161-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2004-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076161-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2004-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076161-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2004-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076161-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2004-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076161-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2004-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076161-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2004-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076161-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2004-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076161-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2004-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076161-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2004-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076161-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2004-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076161-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2004-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076161-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2004-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076161-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2004-06-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076161-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2004-06-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076161-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2004-06-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076161-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2004-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076161-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2004-06-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076161-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2004-06-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076161-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2004-06-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076161-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2004-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076161-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2004-06-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076161-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2004-06-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076161-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2004-06-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076161-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2004-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076161-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2004-06-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076161-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2004-06-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076161-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2004-06-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076161-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2004-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076161-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2004-06-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076161-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2004-06-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076161-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2004-06-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076161-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2004-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076161-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2004-06-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076161-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2004-06-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076161-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2004-06-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076161-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2004-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076161-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2004-06-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076161-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2004-06-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076161-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2004-06-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076161-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2004-06-10d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076161-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076161-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076161-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076161-004AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076161-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076161-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076161-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076161-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076161-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076161-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076161-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076161-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076161-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076161-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076161-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076161-004AB1ea99ee380514…

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67253-380-10EA - Each67253-380c82c11df-6c6f-4173-9bc4-15117baac01512013-02-13
67253-380-11EA - Each67253-380cad7d876-0282-4e47-9f28-dcd74e7b25c012014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN MESYLATE TABLET [DAVA PHARMACEUTICALS, INC.]7
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN MESYLATE TABLET [DAVA PHARMACEUTICALS, INC.]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DOXAZOSIN MESYLATE TABLET [DAVA PHARMACEUTICALS, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN MESYLATE TABLET [DAVA PHARMACEUTICALS, INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXAZOSIN MESYLATE TABLET [DAVA PHARMACEUTICALS, INC.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXAZOSIN MESYLATE TABLET [DAVA PHARMACEUTICALS, INC.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXAZOSIN MESYLATE TABLET [DAVA PHARMACEUTICALS, INC.]7
LACTOSE, UNSPECIFIED FORMINACTIVE INGREDIENTJ2B2A4N98GDOXAZOSIN MESYLATE TABLET [DAVA PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN MESYLATE TABLET [DAVA PHARMACEUTICALS, INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXAZOSIN MESYLATE TABLET [DAVA PHARMACEUTICALS, INC.]7
SODIUM STARCH GLYCOLATE TYPE B POTATOINACTIVE INGREDIENT27NA468985DOXAZOSIN MESYLATE TABLET [DAVA PHARMACEUTICALS, INC.]7
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN MESYLATE TABLET [DISPENSING SOLUTIONS, INC.]1
doxazosin mesylateACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN MESYLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN MESYLATE TABLET [BLENHEIM PHARMACAL, INC.]1
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN MESYLATE TABLET [BLENHEIM PHARMACAL, INC.]1
doxazosinACTIVE MOIETYNW1291F1W8DOXAZOSIN MESYLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN MESYLATE TABLET [DISPENSING SOLUTIONS, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DOXAZOSIN MESYLATE TABLET [BLENHEIM PHARMACAL, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN MESYLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN MESYLATE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN MESYLATE TABLET [DISPENSING SOLUTIONS, INC.]1
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GDOXAZOSIN MESYLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXAZOSIN MESYLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8DOXAZOSIN MESYLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXAZOSIN MESYLATE TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDOXAZOSIN MESYLATE TABLET [DISPENSING SOLUTIONS, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDOXAZOSIN MESYLATE TABLET [BLENHEIM PHARMACAL, INC.]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GDOXAZOSIN MESYLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN MESYLATE TABLET [DISPENSING SOLUTIONS, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXAZOSIN MESYLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN MESYLATE TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXAZOSIN MESYLATE TABLET [DISPENSING SOLUTIONS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXAZOSIN MESYLATE TABLET [BLENHEIM PHARMACAL, INC.]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDOXAZOSIN MESYLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2DOXAZOSIN MESYLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM STARCH GLYCOLATE TYPE B POTATOINACTIVE INGREDIENT27NA468985DOXAZOSIN MESYLATE TABLET [DISPENSING SOLUTIONS, INC.]1
SODIUM STARCH GLYCOLATE TYPE B POTATOINACTIVE INGREDIENT27NA468985DOXAZOSIN MESYLATE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSN2892f3c2-bff6-4411-adf3-fa065ac7c3621
197625doxazosin mesylate 1 MG Oral TabletPSN7d5b94bd-bd39-414d-855e-b8e6f22e593e1
197627doxazosin mesylate 4 MG Oral TabletPSN2892f3c2-bff6-4411-adf3-fa065ac7c3621
197625doxazosin 1 MG Oral TabletSCD2892f3c2-bff6-4411-adf3-fa065ac7c3621
197625doxazosin 1 MG Oral TabletSCD7d5b94bd-bd39-414d-855e-b8e6f22e593e1
197627doxazosin 4 MG Oral TabletSCD2892f3c2-bff6-4411-adf3-fa065ac7c3621
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY2892f3c2-bff6-4411-adf3-fa065ac7c3621
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY7d5b94bd-bd39-414d-855e-b8e6f22e593e1
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY2892f3c2-bff6-4411-adf3-fa065ac7c3621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67253-380-1067253038010100 TABLET in 1 BOTTLE (67253-380-10) 100 tablet2004-06-102021-02-28NoNoCurrent