FDA.reportPublic FDA data

Doxazosin

Product NDC
0904-5523
11-digit product format
009045523
Labeler code
0904
Product ID
0904-5523_ec0e1a20-88d4-457b-88fa-eff3071d0b9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075580
Marketing category
ANDA
Marketing start
2011-07-14
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
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 MESYLATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86P6PQK0MU
Rxcui197625, 197626, 197627

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
0904-5523-61Doxazosin1 in 1 BLISTER PACKTABLET113
0904-5523-61Doxazosin100 in 1 CARTONTABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5523-60EA - Each0904-552331afe72d-93b1-4d63-9962-a20aca5615bb12013-05-02
0904-5523-61EA - Each0904-5523ac2a8de9-ab97-41db-a7df-f55c947daa0c12016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]1
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5523DOXAZOSIN TABLET [MAJOR PHARMACEUTICALS]12Current NDC, Legacy NDC, 2 package rows20250418_3354196f-bbcf-4bc5-94f6-e6e8e132acb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 TabletPSN08521333-ff21-45ad-b99e-1f43d945d24d6
197626doxazosin 2 MG Oral TabletSCD08521333-ff21-45ad-b99e-1f43d945d24d6
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY08521333-ff21-45ad-b99e-1f43d945d24d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5523-6100904552361100 BLISTER PACK in 1 CARTON (0904-5523-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2011-07-140000-00-00NoNoCurrent