FDA.reportPublic FDA data

Doxazosin

Product NDC
60505-0096
11-digit product format
605050096
Labeler code
60505
Product ID
60505-0096_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
8 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 MESYLATE8 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
60505-0096-0Doxazosin100 in 1 BOTTLETABLET10015
60505-0096-1Doxazosin1000 in 1 BOTTLETABLET100015
60505-0096-8Doxazosin5000 in 1 BOTTLETABLET500015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0096-0EA - Each60505-00963376beac-ff37-4222-b9b3-6b5152d454ef12012-07-24
60505-0096-1EA - Each60505-0096a9f32422-499b-4773-83b8-1da702f75b7612012-07-24
60505-0096-8EA - Each60505-0096bfa68409-7688-4ec4-a78b-de674507a91d12013-05-02

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 (DOXAZOSIN) TABLET [AVKARE, INC.]1
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0096DOXAZOSIN TABLET [APOTEX CORP.]14Current NDC, Legacy NDC, 3 package rows20240822_4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
197626doxazosin mesylate 2 MG Oral TabletPSNe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197627doxazosin mesylate 4 MG Oral TabletPSNe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197628doxazosin mesylate 8 MG Oral TabletPSNe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197626doxazosin 2 MG Oral TabletSCDe3d381c1-3b2f-af70-f4e6-08d6202eed2510
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 TabletSYe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYe3d381c1-3b2f-af70-f4e6-08d6202eed2510
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
197628doxazosin mesylate 8 MG Oral TabletPSN2e5cd8cb-7d43-e7af-e063-6294a90a310e1
197628doxazosin 8 MG Oral TabletSCD2e5cd8cb-7d43-e7af-e063-6294a90a310e1
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY2e5cd8cb-7d43-e7af-e063-6294a90a310e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0096-060505009600100 TABLET in 1 BOTTLE (60505-0096-0) 100 tablet2011-07-140000-00-00NoNoCurrent
60505-0096-1605050096011000 TABLET in 1 BOTTLE (60505-0096-1) 1000 tablet2011-07-140000-00-00NoNoCurrent
60505-0096-8605050096085000 TABLET in 1 BOTTLE (60505-0096-8) 5000 tablet2011-07-140000-00-00NoNoCurrent