FDA.reportPublic FDA data

Doxazosin

Product NDC
68788-8412
11-digit product format
687888412
Labeler code
68788
Product ID
68788-8412_20678ec9-2943-4e9c-8a7c-86c6ca5335e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075580
Marketing category
ANDA
Marketing start
2023-04-06
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxazosin
Listing expiration
2027-12-31

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
68788-8412-1Doxazosin100 in 1 BOTTLETABLET1004
68788-8412-3Doxazosin30 in 1 BOTTLETABLET304
68788-8412-6Doxazosin60 in 1 BOTTLETABLET604
68788-8412-9Doxazosin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8412-1EA - Each68788-8412e58a2b5b-6356-4fbd-abed-ee24c9f8bc4312023-06-06
68788-8412-3EA - Each68788-84123eddd3e7-3f5b-4a6a-962f-a0ae0e23417112023-06-06
68788-8412-6EA - Each68788-841265046aeb-8788-41cc-85b8-98ccb51946d012023-06-06
68788-8412-9EA - Each68788-8412bc6eecee-9e63-4e45-90bd-8dc220e46bc412023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8412DOXAZOSIN TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250406_2110eec5-949d-4718-ad6d-3629e5db8a07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197627doxazosin mesylate 4 MG Oral TabletPSN2110eec5-949d-4718-ad6d-3629e5db8a074
197627doxazosin 4 MG Oral TabletSCD2110eec5-949d-4718-ad6d-3629e5db8a074
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY2110eec5-949d-4718-ad6d-3629e5db8a074

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8412-168788841201100 TABLET in 1 BOTTLE (68788-8412-1) 100 tablet2023-04-06NoNoHistorical
68788-8412-36878884120330 TABLET in 1 BOTTLE (68788-8412-3) 30 tablet2023-04-06NoNoHistorical
68788-8412-66878884120660 TABLET in 1 BOTTLE (68788-8412-6) 60 tablet2023-04-06NoNoHistorical
68788-8412-96878884120990 TABLET in 1 BOTTLE (68788-8412-9) 90 tablet2023-04-06NoNoHistorical