FDA.reportPublic FDA data

Doxazosin

Product NDC
68788-8422
11-digit product format
687888422
Labeler code
68788
Product ID
68788-8422_bdf38af7-2a7c-42e2-9872-944871d69a99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075580
Marketing category
ANDA
Marketing start
2023-04-13
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
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 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
68788-8422-1Doxazosin100 in 1 BOTTLETABLET1004
68788-8422-3Doxazosin30 in 1 BOTTLETABLET304
68788-8422-6Doxazosin60 in 1 BOTTLETABLET604
68788-8422-9Doxazosin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8422-1EA - Each68788-84228d044ebf-834b-4c03-8b1f-5706f3d6a61712023-06-06
68788-8422-3EA - Each68788-84226035ad98-f0e7-4e68-8c79-2d32e4d8b02a12023-06-06
68788-8422-6EA - Each68788-84221029a48b-5700-4017-a2c2-7ac64e78da2912023-06-06
68788-8422-9EA - Each68788-84221a02294b-c9b7-4f04-94bb-5d94dd56450112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8422DOXAZOSIN TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250406_e046e0b7-f510-4318-9884-034d683864d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197626doxazosin mesylate 2 MG Oral TabletPSNe046e0b7-f510-4318-9884-034d683864d44
197626doxazosin 2 MG Oral TabletSCDe046e0b7-f510-4318-9884-034d683864d44
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYe046e0b7-f510-4318-9884-034d683864d44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8422-168788842201100 TABLET in 1 BOTTLE (68788-8422-1) 100 tablet2023-04-13NoNoHistorical
68788-8422-36878884220330 TABLET in 1 BOTTLE (68788-8422-3) 30 tablet2023-04-13NoNoHistorical
68788-8422-66878884220660 TABLET in 1 BOTTLE (68788-8422-6) 60 tablet2023-04-13NoNoHistorical
68788-8422-96878884220990 TABLET in 1 BOTTLE (68788-8422-9) 90 tablet2023-04-13NoNoHistorical