FDA.reportPublic FDA data

Doxazosin

Product NDC
50090-6298
11-digit product format
500906298
Labeler code
50090
Product ID
50090-6298_5610e0a8-46eb-4037-88e9-23e46b92b0fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209013
Marketing category
ANDA
Marketing start
2018-04-17
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6298-0Doxazosin30 in 1 BOTTLETABLET305
50090-6298-1Doxazosin100 in 1 BOTTLETABLET1005
50090-6298-2Doxazosin90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6298-0EA - Each50090-6298368a9dcf-6f35-4a62-8bcf-63a16f9712b612023-02-06
50090-6298-1EA - Each50090-62983ecda3d7-1131-4d0e-9ab2-495fdaa826d612023-02-06
50090-6298-2EA - Each50090-629827eed49f-ea09-4824-967a-b1b44e6f1abf12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6298DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 3 package rows20240615_b4c974ad-cbd6-4811-ab48-461e7ffa99f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197627doxazosin mesylate 4 MG Oral TabletPSNb4c974ad-cbd6-4811-ab48-461e7ffa99f75
197627doxazosin 4 MG Oral TabletSCDb4c974ad-cbd6-4811-ab48-461e7ffa99f75
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYb4c974ad-cbd6-4811-ab48-461e7ffa99f75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6298-05009062980030 TABLET in 1 BOTTLE (50090-6298-0) 30 tablet2022-12-290000-00-00NoNoCurrent
50090-6298-150090629801100 TABLET in 1 BOTTLE (50090-6298-1) 100 tablet2022-12-290000-00-00NoNoCurrent
50090-6298-25009062980290 TABLET in 1 BOTTLE (50090-6298-2) 90 tablet2022-12-290000-00-00NoNoCurrent