FDA.reportPublic FDA data

Doxazosin

Product NDC
50090-3143
11-digit product format
500903143
Labeler code
50090
Product ID
50090-3143_4e11209a-907e-4840-8413-2bc9922ea162
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075536
Marketing category
ANDA
Marketing start
2014-12-05
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
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 MESYLATE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86P6PQK0MU
Rxcui197628

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
50090-3143-0Doxazosin30 in 1 BOTTLETABLET3011
50090-3143-1Doxazosin100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3143-0EA - Each50090-3143e753572d-1215-49cf-acd7-90e0e1f98cde12022-12-07
50090-3143-1EA - Each50090-31439759bec4-afc2-40b4-8804-9d38bfafe58a12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3143DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20241023_9b6170e7-814a-46ef-b068-cf3e6508d5e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197628doxazosin mesylate 8 MG Oral TabletPSN9b6170e7-814a-46ef-b068-cf3e6508d5e111
197628doxazosin 8 MG Oral TabletSCD9b6170e7-814a-46ef-b068-cf3e6508d5e111
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY9b6170e7-814a-46ef-b068-cf3e6508d5e111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3143-05009031430030 TABLET in 1 BOTTLE (50090-3143-0) 30 tablet2021-10-280000-00-00NoNoCurrent
50090-3143-150090314301100 TABLET in 1 BOTTLE (50090-3143-1) 100 tablet2017-09-270000-00-00NoNoCurrent