FDA.reportPublic FDA data

Doxazosin

Product NDC
71335-0349
11-digit product format
713350349
Labeler code
71335
Product ID
71335-0349_df1e5ab6-5900-4fbe-a448-f5da91047d1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202824
Marketing category
ANDA
Marketing start
2015-04-22
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
71335-0349-1Doxazosin100 in 1 BOTTLETABLET100102
71335-0349-2Doxazosin30 in 1 BOTTLETABLET30102
71335-0349-3Doxazosin60 in 1 BOTTLETABLET60102
71335-0349-4Doxazosin90 in 1 BOTTLETABLET90102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0349DOXAZOSIN TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 4 package rows20240913_ac4cd22b-2a03-47b6-9eed-550be278f17d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197627doxazosin mesylate 4 MG Oral TabletPSNac4cd22b-2a03-47b6-9eed-550be278f17d102
197627doxazosin 4 MG Oral TabletSCDac4cd22b-2a03-47b6-9eed-550be278f17d102
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYac4cd22b-2a03-47b6-9eed-550be278f17d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0349-171335034901100 TABLET in 1 BOTTLE (71335-0349-1) 100 tablet2024-09-050000-00-00NoNoCurrent
71335-0349-27133503490230 TABLET in 1 BOTTLE (71335-0349-2) 30 tablet2018-07-030000-00-00NoNoCurrent
71335-0349-37133503490360 TABLET in 1 BOTTLE (71335-0349-3) 60 tablet2024-09-050000-00-00NoNoCurrent
71335-0349-47133503490490 TABLET in 1 BOTTLE (71335-0349-4) 90 tablet2018-05-030000-00-00NoNoCurrent