FDA.reportPublic FDA data

Doxazosin

Product NDC
16729-213
11-digit product format
167290213
Labeler code
16729
Product ID
16729-213_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
2015-04-22
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
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 MESYLATE4 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
16729-213-01Doxazosin100 in 1 BOTTLETABLET10011
16729-213-17Doxazosin1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-213-01EA - Each16729-213a3ff3801-0958-49e2-aec0-8a39b8162e2912015-04-03
16729-213-17EA - Each16729-213f5504b45-e2cd-4007-b342-b10c4192a2af12015-04-03

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
16729-213DOXAZOSIN 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
197627doxazosin mesylate 4 MG Oral TabletPSNac4cd22b-2a03-47b6-9eed-550be278f17d102
197627doxazosin 4 MG Oral TabletSCDac4cd22b-2a03-47b6-9eed-550be278f17d102
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYac4cd22b-2a03-47b6-9eed-550be278f17d102
197625doxazosin mesylate 1 MG Oral TabletPSN4034fb6d-f55d-4df0-b500-d6a413591f6e43
197626doxazosin mesylate 2 MG Oral TabletPSN4034fb6d-f55d-4df0-b500-d6a413591f6e43
197627doxazosin mesylate 4 MG Oral TabletPSN4034fb6d-f55d-4df0-b500-d6a413591f6e43
197628doxazosin mesylate 8 MG Oral TabletPSN4034fb6d-f55d-4df0-b500-d6a413591f6e43
197625doxazosin 1 MG Oral TabletSCD4034fb6d-f55d-4df0-b500-d6a413591f6e43
197626doxazosin 2 MG Oral TabletSCD4034fb6d-f55d-4df0-b500-d6a413591f6e43
197627doxazosin 4 MG Oral TabletSCD4034fb6d-f55d-4df0-b500-d6a413591f6e43
197628doxazosin 8 MG Oral TabletSCD4034fb6d-f55d-4df0-b500-d6a413591f6e43
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY4034fb6d-f55d-4df0-b500-d6a413591f6e43
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY4034fb6d-f55d-4df0-b500-d6a413591f6e43
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY4034fb6d-f55d-4df0-b500-d6a413591f6e43
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY4034fb6d-f55d-4df0-b500-d6a413591f6e43
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 TabletPSN40e47e75-6a47-323b-e054-00144ff8d46c6
197627doxazosin 4 MG Oral TabletSCD40e47e75-6a47-323b-e054-00144ff8d46c6
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY40e47e75-6a47-323b-e054-00144ff8d46c6
197627doxazosin mesylate 4 MG Oral TabletPSNf2b35586-d550-3fcb-e053-2995a90a34035
197627doxazosin 4 MG Oral TabletSCDf2b35586-d550-3fcb-e053-2995a90a34035
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYf2b35586-d550-3fcb-e053-2995a90a34035
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
197627doxazosin mesylate 4 MG Oral TabletPSN8de7d5ee-7f9d-447a-af76-7a7fbf3eb33d1
197627doxazosin 4 MG Oral TabletSCD8de7d5ee-7f9d-447a-af76-7a7fbf3eb33d1
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY8de7d5ee-7f9d-447a-af76-7a7fbf3eb33d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-213-0116729021301100 TABLET in 1 BOTTLE (16729-213-01) 100 tablet2015-04-220000-00-00NoNoCurrent
16729-213-17167290213171000 TABLET in 1 BOTTLE (16729-213-17) 1000 tablet2016-07-280000-00-00NoNoCurrent