FDA.reportPublic FDA data

Doxazosin

Product NDC
60505-0095
11-digit product format
605050095
Labeler code
60505
Product ID
60505-0095_7e2e0788-60a4-f586-7ece-7b27d5068dc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA075580
Marketing category
ANDA
Marketing start
2011-07-14
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86P6PQK0MU
Rxcui197625, 197626, 197627, 197628

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0095-0Doxazosin100 in 1 BOTTLETABLET10015
60505-0095-1Doxazosin1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0095-0EA - Each60505-00952e651465-f3e3-4b83-8513-aee1df66cc0312012-07-24
60505-0095-1EA - Each60505-0095f80ca321-69aa-4509-9406-185f1a18fbca12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN TABLET [APOTEX CORP.]4
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN TABLET [APOTEX CORP.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN TABLET [APOTEX CORP.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXAZOSIN TABLET [APOTEX CORP.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXAZOSIN TABLET [APOTEX CORP.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN TABLET [APOTEX CORP.]4
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN TABLET [AMERICAN HEALTH PACKAGING]1
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]1
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN TABLET [AMERICAN HEALTH PACKAGING]1
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN TABLET [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXAZOSIN TABLET [AMERICAN HEALTH PACKAGING]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXAZOSIN TABLET [AMERICAN HEALTH PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0095DOXAZOSIN TABLET [APOTEX CORP.]14Current NDC, Legacy NDC, 2 package rows20240822_4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197627doxazosin mesylate 4 MG Oral TabletPSN54549d19-6311-4dbb-8622-fd3e5440551a102
197627doxazosin 4 MG Oral TabletSCD54549d19-6311-4dbb-8622-fd3e5440551a102
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY54549d19-6311-4dbb-8622-fd3e5440551a102
197625doxazosin mesylate 1 MG Oral TabletPSNbfea0b5b-9354-490f-88ff-008134077d2430
197626doxazosin mesylate 2 MG Oral TabletPSNbfea0b5b-9354-490f-88ff-008134077d2430
197627doxazosin mesylate 4 MG Oral TabletPSNbfea0b5b-9354-490f-88ff-008134077d2430
197628doxazosin mesylate 8 MG Oral TabletPSNbfea0b5b-9354-490f-88ff-008134077d2430
197625doxazosin 1 MG Oral TabletSCDbfea0b5b-9354-490f-88ff-008134077d2430
197626doxazosin 2 MG Oral TabletSCDbfea0b5b-9354-490f-88ff-008134077d2430
197627doxazosin 4 MG Oral TabletSCDbfea0b5b-9354-490f-88ff-008134077d2430
197628doxazosin 8 MG Oral TabletSCDbfea0b5b-9354-490f-88ff-008134077d2430
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSYbfea0b5b-9354-490f-88ff-008134077d2430
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYbfea0b5b-9354-490f-88ff-008134077d2430
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYbfea0b5b-9354-490f-88ff-008134077d2430
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYbfea0b5b-9354-490f-88ff-008134077d2430
197625doxazosin mesylate 1 MG Oral TabletPSN4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b15
197626doxazosin mesylate 2 MG Oral TabletPSN4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b15
197627doxazosin mesylate 4 MG Oral TabletPSN4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b15
197628doxazosin mesylate 8 MG Oral TabletPSN4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b15
197625doxazosin 1 MG Oral TabletSCD4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b15
197626doxazosin 2 MG Oral TabletSCD4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b15
197627doxazosin 4 MG Oral TabletSCD4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b15
197628doxazosin 8 MG Oral TabletSCD4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b15
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b15
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b15
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b15
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b15
197625doxazosin mesylate 1 MG Oral TabletPSN3354196f-bbcf-4bc5-94f6-e6e8e132acb113
197626doxazosin mesylate 2 MG Oral TabletPSN3354196f-bbcf-4bc5-94f6-e6e8e132acb113
197627doxazosin mesylate 4 MG Oral TabletPSN3354196f-bbcf-4bc5-94f6-e6e8e132acb113
197625doxazosin 1 MG Oral TabletSCD3354196f-bbcf-4bc5-94f6-e6e8e132acb113
197626doxazosin 2 MG Oral TabletSCD3354196f-bbcf-4bc5-94f6-e6e8e132acb113
197627doxazosin 4 MG Oral TabletSCD3354196f-bbcf-4bc5-94f6-e6e8e132acb113
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY3354196f-bbcf-4bc5-94f6-e6e8e132acb113
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY3354196f-bbcf-4bc5-94f6-e6e8e132acb113
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY3354196f-bbcf-4bc5-94f6-e6e8e132acb113
197626doxazosin mesylate 2 MG Oral TabletPSNe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197627doxazosin mesylate 4 MG Oral TabletPSNe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197627doxazosin mesylate 4 MG Oral TabletPSN40620f8e-fd36-4634-9cf6-120138d2318710
197628doxazosin mesylate 8 MG Oral TabletPSNe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197626doxazosin 2 MG Oral TabletSCDe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197627doxazosin 4 MG Oral TabletSCD40620f8e-fd36-4634-9cf6-120138d2318710
197627doxazosin 4 MG Oral TabletSCDe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197628doxazosin 8 MG Oral TabletSCDe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY40620f8e-fd36-4634-9cf6-120138d2318710
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197625doxazosin mesylate 1 MG Oral TabletPSN3f4dc1a7-05e6-41d7-908c-30ce2677d87b9
197626doxazosin mesylate 2 MG Oral TabletPSN3f4dc1a7-05e6-41d7-908c-30ce2677d87b9
197627doxazosin mesylate 4 MG Oral TabletPSN3f4dc1a7-05e6-41d7-908c-30ce2677d87b9
197625doxazosin 1 MG Oral TabletSCD3f4dc1a7-05e6-41d7-908c-30ce2677d87b9
197626doxazosin 2 MG Oral TabletSCD3f4dc1a7-05e6-41d7-908c-30ce2677d87b9
197627doxazosin 4 MG Oral TabletSCD3f4dc1a7-05e6-41d7-908c-30ce2677d87b9
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY3f4dc1a7-05e6-41d7-908c-30ce2677d87b9
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY3f4dc1a7-05e6-41d7-908c-30ce2677d87b9
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY3f4dc1a7-05e6-41d7-908c-30ce2677d87b9
197627doxazosin mesylate 4 MG Oral TabletPSN505d3c4c-5506-72cc-e054-00144ff88e884
197627doxazosin mesylate 4 MG Oral TabletPSNbf2f7b41-f14d-4fcd-8db3-f507ca6ff78b4
197627doxazosin mesylate 4 MG Oral TabletPSN2110eec5-949d-4718-ad6d-3629e5db8a074
197627doxazosin 4 MG Oral TabletSCD505d3c4c-5506-72cc-e054-00144ff88e884
197627doxazosin 4 MG Oral TabletSCD2110eec5-949d-4718-ad6d-3629e5db8a074
197627doxazosin 4 MG Oral TabletSCDbf2f7b41-f14d-4fcd-8db3-f507ca6ff78b4
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYbf2f7b41-f14d-4fcd-8db3-f507ca6ff78b4
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY505d3c4c-5506-72cc-e054-00144ff88e884
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY2110eec5-949d-4718-ad6d-3629e5db8a074
197625doxazosin mesylate 1 MG Oral TabletPSNde9ab9a4-d8b8-8b36-e053-2a95a90aaa353
197626doxazosin mesylate 2 MG Oral TabletPSNde9ab9a4-d8b8-8b36-e053-2a95a90aaa353
197627doxazosin mesylate 4 MG Oral TabletPSNde9ab9a4-d8b8-8b36-e053-2a95a90aaa353
197628doxazosin mesylate 8 MG Oral TabletPSNde9ab9a4-d8b8-8b36-e053-2a95a90aaa353
197625doxazosin 1 MG Oral TabletSCDde9ab9a4-d8b8-8b36-e053-2a95a90aaa353
197626doxazosin 2 MG Oral TabletSCDde9ab9a4-d8b8-8b36-e053-2a95a90aaa353
197627doxazosin 4 MG Oral TabletSCDde9ab9a4-d8b8-8b36-e053-2a95a90aaa353
197628doxazosin 8 MG Oral TabletSCDde9ab9a4-d8b8-8b36-e053-2a95a90aaa353
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSYde9ab9a4-d8b8-8b36-e053-2a95a90aaa353
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYde9ab9a4-d8b8-8b36-e053-2a95a90aaa353
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYde9ab9a4-d8b8-8b36-e053-2a95a90aaa353
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYde9ab9a4-d8b8-8b36-e053-2a95a90aaa353
197627doxazosin mesylate 4 MG Oral TabletPSN0ae00cc4-9e6b-42bb-9d3c-c5d2e45fde1a1
197627doxazosin mesylate 4 MG Oral TabletPSN1d8ff659-8129-4dca-9e8f-13b97240d1e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0095-060505009500100 TABLET in 1 BOTTLE (60505-0095-0) 100 tablet2011-07-140000-00-00NoNoCurrent
60505-0095-1605050095011000 TABLET in 1 BOTTLE (60505-0095-1) 1000 tablet2011-07-140000-00-00NoNoCurrent