FDA.reportPublic FDA data

Doxazosin

Product NDC
50090-3927
11-digit product format
500903927
Labeler code
50090
Product ID
50090-3927_ab9e7c32-0e80-4871-bdb2-5190cc4fdd5f
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
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
50090-3927-12023-05-17C16284748780-1f386c64a-0e3f-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
50090-3927-12023-01-30C16284748780-1f386c64a-0e3f-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
50090-3927-0Doxazosin30 in 1 BOTTLETABLET308
50090-3927-1Doxazosin100 in 1 BOTTLETABLET1008
50090-3927-2Doxazosin90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3927-0EA - Each50090-39275d63f123-4b7c-4bd1-a8bc-59c1a73c614112023-06-06
50090-3927-1EA - Each50090-39272b6b5387-966c-4b8f-ac82-62915c2f263412023-06-06
50090-3927-2EA - Each50090-392778c2e572-734b-43b7-bc91-f38d240e9f4112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3927DOXAZOSIN TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 3 package rows20240612_46b01b1d-c48a-4c36-bf3c-bba98066166c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197627doxazosin mesylate 4 MG Oral TabletPSN46b01b1d-c48a-4c36-bf3c-bba98066166c8
197627doxazosin 4 MG Oral TabletSCD46b01b1d-c48a-4c36-bf3c-bba98066166c8
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY46b01b1d-c48a-4c36-bf3c-bba98066166c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3927-05009039270030 TABLET in 1 BOTTLE (50090-3927-0) 30 tablet2018-12-07NoNoCurrent
50090-3927-150090392701100 TABLET in 1 BOTTLE (50090-3927-1) 100 tablet2018-12-070000-00-00NoNoCurrent
50090-3927-25009039270290 TABLET in 1 BOTTLE (50090-3927-2) 90 tablet2023-05-10NoNoCurrent