FDA.reportPublic FDA data

Doxazosin

Product NDC
63629-7891
11-digit product format
636297891
Labeler code
63629
Product ID
63629-7891_15e8d491-97fb-485f-935b-7b74d58c88ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202824
Marketing category
ANDA
Marketing start
2015-03-04
Substance
DOXAZOSIN MESYLATE
Active strength
1 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 MESYLATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86P6PQK0MU
Rxcui197625

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
63629-7891-12024-04-26C16284748780-11030e365-327f-111a-e063-dadaa90a10e2These 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
63629-7891-22024-04-26C16284748780-11030e365-327f-111a-e063-dadaa90a10e2These 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
63629-7891-12024-01-30C16284748780-11030e365-327f-111a-e063-dadaa90a10e2These 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
63629-7891-22024-01-30C16284748780-11030e365-327f-111a-e063-dadaa90a10e2These 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
63629-7891-1Doxazosin30 in 1 BOTTLETABLET305
63629-7891-2Doxazosin90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7891DOXAZOSIN TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 2 package rows20240912_8c0c0345-833b-4a3d-9081-da66b208d750.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSN8c0c0345-833b-4a3d-9081-da66b208d7505
197625doxazosin 1 MG Oral TabletSCD8c0c0345-833b-4a3d-9081-da66b208d7505
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY8c0c0345-833b-4a3d-9081-da66b208d7505

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7891-16362978910130 TABLET in 1 BOTTLE (63629-7891-1) 30 tablet2024-09-050000-00-00NoNoCurrent
63629-7891-26362978910290 TABLET in 1 BOTTLE (63629-7891-2) 90 tablet2019-01-110000-00-00NoNoCurrent