FDA.reportPublic FDA data

Doxazosin

Product NDC
59651-895
11-digit product format
596510895
Labeler code
59651
Product ID
59651-895_a3c03b74-51e7-4df3-a5db-78e4453e52aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxazosin mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA075509
Marketing category
ANDA
Marketing start
2024-03-01
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
59651-895-01Doxazosin100 in 1 BOTTLETABLET1002
59651-895-99Doxazosin1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-895-01EA - Each59651-895060ad0e2-128a-4708-a46f-7de19fee53d212024-11-05
59651-895-99EA - Each59651-895091ad4e7-366f-42c0-a848-d362718e604d12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-895DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [AUROBINDO PHARMA LIMITED]2Current NDC, 2 package rows20241009_93f2d724-5a54-4721-b04a-e46bc764607b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSN93f2d724-5a54-4721-b04a-e46bc764607b2
197626doxazosin mesylate 2 MG Oral TabletPSN93f2d724-5a54-4721-b04a-e46bc764607b2
197627doxazosin mesylate 4 MG Oral TabletPSN93f2d724-5a54-4721-b04a-e46bc764607b2
197628doxazosin mesylate 8 MG Oral TabletPSN93f2d724-5a54-4721-b04a-e46bc764607b2
197625doxazosin 1 MG Oral TabletSCD93f2d724-5a54-4721-b04a-e46bc764607b2
197626doxazosin 2 MG Oral TabletSCD93f2d724-5a54-4721-b04a-e46bc764607b2
197627doxazosin 4 MG Oral TabletSCD93f2d724-5a54-4721-b04a-e46bc764607b2
197628doxazosin 8 MG Oral TabletSCD93f2d724-5a54-4721-b04a-e46bc764607b2
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY93f2d724-5a54-4721-b04a-e46bc764607b2
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY93f2d724-5a54-4721-b04a-e46bc764607b2
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY93f2d724-5a54-4721-b04a-e46bc764607b2
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY93f2d724-5a54-4721-b04a-e46bc764607b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-895-0159651089501100 TABLET in 1 BOTTLE (59651-895-01) 100 tablet2024-03-01NoNoHistorical
59651-895-99596510895991000 TABLET in 1 BOTTLE (59651-895-99) 1000 tablet2024-03-01NoNoHistorical