FDA.reportPublic FDA data

Doxazosin

Product NDC
71610-160
11-digit product format
716100160
Labeler code
71610
Product ID
71610-160_c783db8d-05dc-4b11-9f6a-bcb821b73cac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075580
Marketing category
ANDA
Marketing start
2015-04-09
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
Rxcui197626, 197628

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
71610-160-16Doxazosin6000 in 1 BOTTLETABLET60002
71610-160-60Doxazosin90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-160-16EA - Each71610-160dc56e12d-3803-491c-a7cd-5d60ef651ea312018-12-13
71610-160-60EA - Each71610-160ee85c29f-e867-4607-ae64-8b4155043dd012022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-160DOXAZOSIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20211209_f1dc70f6-4329-46da-8990-7bd6eec9d37d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197626doxazosin mesylate 2 MG Oral TabletPSNf1dc70f6-4329-46da-8990-7bd6eec9d37d2
197628doxazosin mesylate 8 MG Oral TabletPSNf1dc70f6-4329-46da-8990-7bd6eec9d37d2
197626doxazosin 2 MG Oral TabletSCDf1dc70f6-4329-46da-8990-7bd6eec9d37d2
197628doxazosin 8 MG Oral TabletSCDf1dc70f6-4329-46da-8990-7bd6eec9d37d2
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYf1dc70f6-4329-46da-8990-7bd6eec9d37d2
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYf1dc70f6-4329-46da-8990-7bd6eec9d37d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-160-16716100160166000 TABLET in 1 BOTTLE (71610-160-16) 6000 tablet2018-09-200000-00-00NoNoCurrent
71610-160-607161001606090 TABLET in 1 BOTTLE (71610-160-60) 90 tablet2021-11-230000-00-00NoNoCurrent