FDA.reportPublic FDA data

Doxazosin

Product NDC
16729-415
11-digit product format
167290415
Labeler code
16729
Product ID
16729-415_1fbdaa94-b68a-b934-e063-6294a90a8b77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202824
Marketing category
ANDA
Marketing start
2017-07-10
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
Rxcui197625, 197626, 197627, 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
16729-415-01Doxazosin100 in 1 BOTTLETABLET10011
16729-415-17Doxazosin1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-415-01EA - Each16729-415e87518d1-8f71-483d-8e36-a42f5815c19912017-08-11
16729-415-17EA - Each16729-41564cceaf3-959b-4aee-b534-aace46b788ab12017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-415DOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]11Current NDC, Legacy NDC, 2 package rows20240816_2830533c-ccdf-4401-b19c-763eeb1bc0a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSN2830533c-ccdf-4401-b19c-763eeb1bc0a711
197626doxazosin mesylate 2 MG Oral TabletPSN2830533c-ccdf-4401-b19c-763eeb1bc0a711
197627doxazosin mesylate 4 MG Oral TabletPSN2830533c-ccdf-4401-b19c-763eeb1bc0a711
197628doxazosin mesylate 8 MG Oral TabletPSN2830533c-ccdf-4401-b19c-763eeb1bc0a711
197625doxazosin 1 MG Oral TabletSCD2830533c-ccdf-4401-b19c-763eeb1bc0a711
197626doxazosin 2 MG Oral TabletSCD2830533c-ccdf-4401-b19c-763eeb1bc0a711
197627doxazosin 4 MG Oral TabletSCD2830533c-ccdf-4401-b19c-763eeb1bc0a711
197628doxazosin 8 MG Oral TabletSCD2830533c-ccdf-4401-b19c-763eeb1bc0a711
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY2830533c-ccdf-4401-b19c-763eeb1bc0a711
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY2830533c-ccdf-4401-b19c-763eeb1bc0a711
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY2830533c-ccdf-4401-b19c-763eeb1bc0a711
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY2830533c-ccdf-4401-b19c-763eeb1bc0a711
197627doxazosin mesylate 4 MG Oral TabletPSN8d40679a-d0cd-39b1-e053-2995a90a40852
197628doxazosin mesylate 8 MG Oral TabletPSN8d40679a-d0cd-39b1-e053-2995a90a40852
197627doxazosin 4 MG Oral TabletSCD8d40679a-d0cd-39b1-e053-2995a90a40852
197628doxazosin 8 MG Oral TabletSCD8d40679a-d0cd-39b1-e053-2995a90a40852
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY8d40679a-d0cd-39b1-e053-2995a90a40852
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY8d40679a-d0cd-39b1-e053-2995a90a40852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-415-0116729041501100 TABLET in 1 BOTTLE (16729-415-01) 100 tablet2017-07-100000-00-00NoNoCurrent
16729-415-17167290415171000 TABLET in 1 BOTTLE (16729-415-17) 1000 tablet2017-07-100000-00-00NoNoCurrent