FDA.reportPublic FDA data

Doxazosin

Product NDC
50090-5773
11-digit product format
500905773
Labeler code
50090
Product ID
50090-5773_6101bbe5-fd09-48bc-9b58-cd7d3df325b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202824
Marketing category
ANDA
Marketing start
2017-06-14
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
Rxcui197626

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
50090-5773-02023-02-07C16284748780-1f386c64a-254b-0266-e053-dadaa90a7c1aThese 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
50090-5773-02023-01-30C16284748780-1f386c64a-254b-0266-e053-dadaa90a7c1aThese 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
50090-5773-0Doxazosin30 in 1 BOTTLETABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5773DOXAZOSIN TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20240612_9f67fa58-f623-4145-9e2c-98feee7ca45f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197626doxazosin mesylate 2 MG Oral TabletPSN9f67fa58-f623-4145-9e2c-98feee7ca45f9
197626doxazosin 2 MG Oral TabletSCD9f67fa58-f623-4145-9e2c-98feee7ca45f9
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY9f67fa58-f623-4145-9e2c-98feee7ca45f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5773-05009057730030 TABLET in 1 BOTTLE (50090-5773-0) 30 tablet2021-10-070000-00-00NoNoCurrent