FDA.reportPublic FDA data

Doxazosin

Product NDC
23155-093
11-digit product format
231550093
Labeler code
23155
Product ID
23155-093_cf1c14bc-a5cc-4800-9ec8-d5fbe267c43c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA205210
Marketing category
ANDA
Marketing start
2018-02-13
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, 197628

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
23155-093-012020-08-05C16284748780-19d75b9d0-3dd5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DOXAZOSIN TABLETS safely and effectively. See full prescribing information for DOXAZOSIN TABLETS. DOXAZOSIN tablets, for oral use Initial U.S. Approval: 1990
23155-093-012020-01-31C16284748780-19d75b9d0-3dd5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DOXAZOSIN TABLETS safely and effectively. See full prescribing information for DOXAZOSIN TABLETS. DOXAZOSIN tablets, for oral use Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-093-01Doxazosin100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-093-01EA - Each23155-0932907b710-25d5-479a-ab61-2e267f668b7512019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-093DOXAZOSIN TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 1 package rows20240705_7991373e-8a62-47f9-b4fb-90573485af4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSN7991373e-8a62-47f9-b4fb-90573485af4e9
197626doxazosin mesylate 2 MG Oral TabletPSN7991373e-8a62-47f9-b4fb-90573485af4e9
197627doxazosin mesylate 4 MG Oral TabletPSN7991373e-8a62-47f9-b4fb-90573485af4e9
197628doxazosin mesylate 8 MG Oral TabletPSN7991373e-8a62-47f9-b4fb-90573485af4e9
197625doxazosin 1 MG Oral TabletSCD7991373e-8a62-47f9-b4fb-90573485af4e9
197626doxazosin 2 MG Oral TabletSCD7991373e-8a62-47f9-b4fb-90573485af4e9
197627doxazosin 4 MG Oral TabletSCD7991373e-8a62-47f9-b4fb-90573485af4e9
197628doxazosin 8 MG Oral TabletSCD7991373e-8a62-47f9-b4fb-90573485af4e9
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY7991373e-8a62-47f9-b4fb-90573485af4e9
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY7991373e-8a62-47f9-b4fb-90573485af4e9
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY7991373e-8a62-47f9-b4fb-90573485af4e9
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY7991373e-8a62-47f9-b4fb-90573485af4e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-093-0123155009301100 TABLET in 1 BOTTLE (23155-093-01) 100 tablet2018-02-130000-00-00NoNoCurrent