FDA.reportPublic FDA data

Doxazosin

Product NDC
0832-0356
11-digit product format
008320356
Labeler code
0832
Product ID
0832-0356_4367e154-1abf-01ad-e063-6394a90aca53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith laboratories, LLC
Application
ANDA209013
Marketing category
ANDA
Marketing start
2018-04-17
Marketing end
2027-08-31
Substance
DOXAZOSIN MESYLATE
Active strength
1 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxazosin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE1 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0832-0356-112023-01-30C16284748780-1ab0e2407-304a-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use DOXAZOSIN TABLETS safely and effectively. See full prescribing information for DOXAZOSIN TABLETS. DOXAZOSIN tablets, for oral use Initial U.S. Approval: 1990
0832-0356-112023-01-30C16284748780-1ab0e2407-304a-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use DOXAZOSIN TABLETS safely and effectively. See full prescribing information for DOXAZOSIN TABLETS. DOXAZOSIN tablets, for oral use Initial U.S. Approval: 1990
0832-0356-112020-07-22C16284748780-1ab0e2407-304a-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use DOXAZOSIN TABLETS safely and effectively. See full prescribing information for DOXAZOSIN TABLETS. DOXAZOSIN tablets, for oral use Initial U.S. Approval: 1990
0832-0356-112020-07-22C16284748780-1ab0e2407-304a-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use DOXAZOSIN TABLETS safely and effectively. See full prescribing information for DOXAZOSIN TABLETS. DOXAZOSIN tablets, for oral use Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-0356-11Doxazosin100 in 1 BOTTLETABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0356-11EA - Each0832-0356857d6f9a-5349-4fc2-b0ff-509313670d9912018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0356DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [UPSHER-SMITH LABORATORIES, LLC]7Current NDC, Legacy NDC, 1 package rows20230519_b5d1c604-ce3b-4973-845f-9db267a945cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSNb5d1c604-ce3b-4973-845f-9db267a945cd8
197626doxazosin mesylate 2 MG Oral TabletPSNb5d1c604-ce3b-4973-845f-9db267a945cd8
197627doxazosin mesylate 4 MG Oral TabletPSNb5d1c604-ce3b-4973-845f-9db267a945cd8
197628doxazosin mesylate 8 MG Oral TabletPSNb5d1c604-ce3b-4973-845f-9db267a945cd8
197625doxazosin 1 MG Oral TabletSCDb5d1c604-ce3b-4973-845f-9db267a945cd8
197626doxazosin 2 MG Oral TabletSCDb5d1c604-ce3b-4973-845f-9db267a945cd8
197627doxazosin 4 MG Oral TabletSCDb5d1c604-ce3b-4973-845f-9db267a945cd8
197628doxazosin 8 MG Oral TabletSCDb5d1c604-ce3b-4973-845f-9db267a945cd8
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSYb5d1c604-ce3b-4973-845f-9db267a945cd8
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYb5d1c604-ce3b-4973-845f-9db267a945cd8
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYb5d1c604-ce3b-4973-845f-9db267a945cd8
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYb5d1c604-ce3b-4973-845f-9db267a945cd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-0356-1100832035611100 TABLET in 1 BOTTLE (0832-0356-11) 100 tablet2018-04-172027-01-31NoNoCurrent