FDA.reportPublic FDA data

Doxazosin

Product NDC
50090-4000
11-digit product format
500904000
Labeler code
50090
Product ID
50090-4000_a0275eb8-586d-425f-9100-4c0f5d56fbc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208719
Marketing category
ANDA
Marketing start
2017-08-31
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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
50090-4000-02023-01-30C16284748780-1f386c649-e2c5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DOXAZOCIN TABLETS safely and effectively. See full prescribing information for DOXAZOCIN TABLETS. DOXAZOSIN TABLETS, for oral use Initial U.S. Approval: 1990
50090-4000-12023-01-30C16284748780-1f386c649-e2c5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DOXAZOCIN TABLETS safely and effectively. See full prescribing information for DOXAZOCIN TABLETS. DOXAZOSIN TABLETS, for oral use Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4000-0Doxazosin30 in 1 BOTTLETABLET306
50090-4000-1Doxazosin100 in 1 BOTTLETABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4000DOXAZOSIN TABLET [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20210831_1dbf8366-c606-4253-aa08-ed555a8de4c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197628doxazosin mesylate 8 MG Oral TabletPSN1dbf8366-c606-4253-aa08-ed555a8de4c36
197628doxazosin 8 MG Oral TabletSCD1dbf8366-c606-4253-aa08-ed555a8de4c36
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY1dbf8366-c606-4253-aa08-ed555a8de4c36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4000-05009040000030 TABLET in 1 BOTTLE (50090-4000-0) 30 tablet2018-12-270000-00-00NoNoCurrent
50090-4000-150090400001100 TABLET in 1 BOTTLE (50090-4000-1) 100 tablet2021-08-260000-00-00NoNoCurrent