FDA.reportPublic FDA data

Doxazosin

Product NDC
71335-2395
11-digit product format
713352395
Labeler code
71335
Product ID
71335-2395_17442115-4aac-79b0-e063-6294a90a84bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208719
Marketing category
ANDA
Marketing start
2017-08-31
Substance
DOXAZOSIN MESYLATE
Active strength
2 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 MESYLATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86P6PQK0MU
Rxcui197626

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
71335-2395-1Doxazosin30 in 1 BOTTLETABLET301
71335-2395-2Doxazosin60 in 1 BOTTLETABLET601
71335-2395-3Doxazosin90 in 1 BOTTLETABLET901
71335-2395-4Doxazosin28 in 1 BOTTLETABLET281
71335-2395-5Doxazosin18 in 1 BOTTLETABLET181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2395DOXAZOSIN TABLET [BRYANT RANCH PREPACK]1Current NDC, 5 package rows20240430_6fbb9ca2-e8ca-45c7-a178-b4c8dd7a9a1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197626doxazosin mesylate 2 MG Oral TabletPSN6fbb9ca2-e8ca-45c7-a178-b4c8dd7a9a1f1
197626doxazosin 2 MG Oral TabletSCD6fbb9ca2-e8ca-45c7-a178-b4c8dd7a9a1f1
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY6fbb9ca2-e8ca-45c7-a178-b4c8dd7a9a1f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2395-17133523950130 TABLET in 1 BOTTLE (71335-2395-1) 30 tablet2024-04-29NoNoCurrent
71335-2395-27133523950260 TABLET in 1 BOTTLE (71335-2395-2) 60 tablet2024-04-29NoNoCurrent
71335-2395-37133523950390 TABLET in 1 BOTTLE (71335-2395-3) 90 tablet2024-04-29NoNoCurrent
71335-2395-47133523950428 TABLET in 1 BOTTLE (71335-2395-4) 28 tablet2024-04-29NoNoCurrent
71335-2395-57133523950518 TABLET in 1 BOTTLE (71335-2395-5) 18 tablet2024-04-29NoNoCurrent