FDA.reportPublic FDA data

Doxazosin

Product NDC
71610-420
11-digit product format
716100420
Labeler code
71610
Product ID
71610-420_70f60997-64ad-4900-aaca-6cc0dbe73def
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA209013
Marketing category
ANDA
Marketing start
2018-04-17
Marketing end
0000-00-00
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
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
71610-420-092023-01-30C16284748780-1f386c649-bd39-0266-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
71610-420-602023-01-30C16284748780-1f386c649-bd39-0266-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
71610-420-09Doxazosin9000 in 1 BOTTLETABLET90002
71610-420-60Doxazosin90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-420-09EA - Each71610-420584c37e4-7486-4ea7-8137-9a2027b912c812021-08-05
71610-420-60EA - Each71610-420d4b0d3d6-d26e-4698-b9c6-a9ecdccddb7012020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-420DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 2 package rows20210703_5836b416-8a54-4ddd-b574-c2f1b8d480f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197627doxazosin mesylate 4 MG Oral TabletPSN5836b416-8a54-4ddd-b574-c2f1b8d480f12
197627doxazosin 4 MG Oral TabletSCD5836b416-8a54-4ddd-b574-c2f1b8d480f12
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY5836b416-8a54-4ddd-b574-c2f1b8d480f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-420-09716100420099000 TABLET in 1 BOTTLE (71610-420-09) 9000 tablet2021-05-130000-00-00NoNoCurrent
71610-420-607161004206090 TABLET in 1 BOTTLE (71610-420-60) 90 tablet2020-04-290000-00-00NoNoCurrent