FDA.reportPublic FDA data

Doxazosin

Product NDC
71335-0309
11-digit product format
713350309
Labeler code
71335
Product ID
71335-0309_b8f7253a-3e90-4663-be31-22d8be29f2a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202824
Marketing category
ANDA
Marketing start
2017-06-14
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
71335-0309-1Doxazosin30 in 1 BOTTLETABLET307
71335-0309-2Doxazosin60 in 1 BOTTLETABLET607
71335-0309-3Doxazosin90 in 1 BOTTLETABLET907
71335-0309-4Doxazosin28 in 1 BOTTLETABLET287
71335-0309-5Doxazosin18 in 1 BOTTLETABLET187

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0309-1EA - Each71335-03097a565fba-9bdd-49fc-9771-46380a93904a12018-09-05
71335-0309-3EA - Each71335-0309516feffd-51fc-4f61-b353-dfd3939ef0b312018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0309DOXAZOSIN TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 5 package rows20240913_ef8b5534-5939-400a-ad5e-f9ceaefc4097.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197626doxazosin mesylate 2 MG Oral TabletPSNef8b5534-5939-400a-ad5e-f9ceaefc40977
197626doxazosin 2 MG Oral TabletSCDef8b5534-5939-400a-ad5e-f9ceaefc40977
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYef8b5534-5939-400a-ad5e-f9ceaefc40977

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0309-17133503090130 TABLET in 1 BOTTLE (71335-0309-1) 30 tablet2018-07-030000-00-00NoNoCurrent
71335-0309-27133503090260 TABLET in 1 BOTTLE (71335-0309-2) 60 tablet2022-01-270000-00-00NoNoCurrent
71335-0309-37133503090390 TABLET in 1 BOTTLE (71335-0309-3) 90 tablet2018-05-030000-00-00NoNoCurrent
71335-0309-47133503090428 TABLET in 1 BOTTLE (71335-0309-4) 28 tablet2024-09-050000-00-00NoNoCurrent
71335-0309-57133503090518 TABLET in 1 BOTTLE (71335-0309-5) 18 tablet2024-09-050000-00-00NoNoCurrent