FDA.reportPublic FDA data

Doxazosin

Product NDC
68071-3298
11-digit product format
680713298
Labeler code
68071
Product ID
68071-3298_1cd594f8-d1a1-de12-e063-6394a90abb53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
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
Rxcui197627

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
68071-3298-32023-03-29C16284748780-1ba0f9c33-228e-a910-e053-dadaa90a0b85These 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
68071-3298-62023-03-29C16284748780-1ba0f9c33-228e-a910-e053-dadaa90a0b85These 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
68071-3298-92023-03-29C16284748780-1ba0f9c33-228e-a910-e053-dadaa90a0b85These 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
68071-3298-32023-01-30C16284748780-1ba0f9c33-228e-a910-e053-dadaa90a0b85These 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
68071-3298-62023-01-30C16284748780-1ba0f9c33-228e-a910-e053-dadaa90a0b85These 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
68071-3298-92023-01-30C16284748780-1ba0f9c33-228e-a910-e053-dadaa90a0b85These 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
68071-3298-32021-02-11C16284748780-1ba0f9c33-228e-a910-e053-dadaa90a0b85These 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
68071-3298-62021-02-11C16284748780-1ba0f9c33-228e-a910-e053-dadaa90a0b85These 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
68071-3298-92021-02-11C16284748780-1ba0f9c33-228e-a910-e053-dadaa90a0b85These 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
68071-3298-32021-01-29C16284748780-1ba0f9c33-228e-a910-e053-dadaa90a0b85These 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
68071-3298-62021-01-29C16284748780-1ba0f9c33-228e-a910-e053-dadaa90a0b85These 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
68071-3298-92021-01-29C16284748780-1ba0f9c33-228e-a910-e053-dadaa90a0b85These 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
68071-3298-3Doxazosin30 in 1 BOTTLETABLET304
68071-3298-6Doxazosin60 in 1 BOTTLETABLET604
68071-3298-9Doxazosin90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3298DOXAZOSIN TABLET [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20240711_505d3c4c-5506-72cc-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197627doxazosin mesylate 4 MG Oral TabletPSN505d3c4c-5506-72cc-e054-00144ff88e884
197627doxazosin 4 MG Oral TabletSCD505d3c4c-5506-72cc-e054-00144ff88e884
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY505d3c4c-5506-72cc-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3298-36807132980330 TABLET in 1 BOTTLE (68071-3298-3) 30 tablet2017-05-250000-00-00NoNoCurrent
68071-3298-66807132980660 TABLET in 1 BOTTLE (68071-3298-6) 60 tablet2017-05-250000-00-00NoNoCurrent
68071-3298-96807132980990 TABLET in 1 BOTTLE (68071-3298-9) 90 tablet2017-05-250000-00-00NoNoCurrent