FDA.reportPublic FDA data

Doxazosin Mesylate

Product NDC
29300-354
11-digit product format
293000354
Labeler code
29300
Product ID
29300-354_e2406e8e-68c2-49dc-9e15-6170f3fffa03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA212329
Marketing category
ANDA
Marketing start
2024-01-10
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 Mesylate
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
29300-354-01Doxazosin Mesylate100 in 1 BOTTLETABLET1004
29300-354-10Doxazosin Mesylate1000 in 1 BOTTLETABLET10004
29300-354-13Doxazosin Mesylate30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-354-01EA - Each29300-35496acdbd8-40b1-4be2-afb8-5ec4045d742f12024-08-12
29300-354-10EA - Each29300-3543b1df464-8f9f-4833-84fa-308b997500f912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-354DOXAZOSIN MESYLATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4Current NDC, 3 package rows20240124_44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSN44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f4
197626doxazosin mesylate 2 MG Oral TabletPSN44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f4
197627doxazosin mesylate 4 MG Oral TabletPSN44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f4
197628doxazosin mesylate 8 MG Oral TabletPSN44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f4
197625doxazosin 1 MG Oral TabletSCD44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f4
197626doxazosin 2 MG Oral TabletSCD44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f4
197627doxazosin 4 MG Oral TabletSCD44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f4
197628doxazosin 8 MG Oral TabletSCD44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f4
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f4
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f4
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f4
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
29300-354-0129300035401100 TABLET in 1 BOTTLE (29300-354-01) 100 tablet2024-03-15NoNoCurrent
29300-354-10293000354101000 TABLET in 1 BOTTLE (29300-354-10) 1000 tablet2024-03-15NoNoCurrent
29300-354-132930003541330 TABLET in 1 BOTTLE (29300-354-13) 30 tablet2024-03-15NoNoCurrent