FDA.reportPublic FDA data

Doxazosin

Product NDC
50090-4000
11-digit product format
500904000
Labeler code
50090
Product ID
50090-4000_a0275eb8-586d-425f-9100-4c0f5d56fbc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208719
Marketing category
ANDA
Marketing start
2017-08-31
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4000IInactivated by FDA2026-08-03
excluded packagepackage50090-400050090-4000-0IInactivated by FDA2026-08-03
excluded packagepackage50090-400050090-4000-1IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208719-001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-07
A208719-002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-07
A208719-003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-07
A208719-004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A208719-001AB
A208719-002AB
A208719-003AB
A208719-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208719-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-07a50c72e98297…
2026-08-01 22:54:322026-06A208719-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-07a50c72e98297…
2026-08-01 22:54:322026-06A208719-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-07a50c72e98297…
2026-08-01 22:54:322026-06A208719-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208719-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208719-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A208719-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A208719-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxazosinDOXAZOSINREMEDYREPACK INC.ec06f008-37a1-4757-a3ee-0b4720912bc42026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINNuCare Pharmaceuticals, Inc.30b709d6-c438-c721-e063-6294a90abd612025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINNuCare Pharmaceuticals,Inc.88efdfb0-710f-768a-e053-2995a90aede42024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINZydus Lifesciences Limitedac889877-133c-4448-af5a-d77b3cbfe8782024-11-28Exact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINA-S Medication Solutions46b01b1d-c48a-4c36-bf3c-bba98066166c2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINAphena Pharma Solutions - Tennessee, LLC187bc51b-7a3a-5910-e063-6294a90aa8882024-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINBryant Ranch Prepack6fbb9ca2-e8ca-45c7-a178-b4c8dd7a9a1f2024-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINZydus Pharmaceuticals USA Inc.e4758bf9-b9d4-4268-beb8-0d7e068908952023-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719

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
50090-4000-02023-01-30C16284748780-1f386c649-e2c5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DOXAZOCIN TABLETS safely and effectively. See full prescribing information for DOXAZOCIN TABLETS. DOXAZOSIN TABLETS, for oral use Initial U.S. Approval: 1990
50090-4000-12023-01-30C16284748780-1f386c649-e2c5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DOXAZOCIN TABLETS safely and effectively. See full prescribing information for DOXAZOCIN TABLETS. DOXAZOSIN TABLETS, for oral use Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4000-0Doxazosin30 in 1 BOTTLETABLET306
50090-4000-1Doxazosin100 in 1 BOTTLETABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4000DOXAZOSIN TABLET [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20210831_1dbf8366-c606-4253-aa08-ed555a8de4c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197628doxazosin mesylate 8 MG Oral TabletPSN1dbf8366-c606-4253-aa08-ed555a8de4c36
197628doxazosin 8 MG Oral TabletSCD1dbf8366-c606-4253-aa08-ed555a8de4c36
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY1dbf8366-c606-4253-aa08-ed555a8de4c36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4000-05009040000030 TABLET in 1 BOTTLE (50090-4000-0) 30 tablet2018-12-270000-00-00NoNoCurrent
50090-4000-150090400001100 TABLET in 1 BOTTLE (50090-4000-1) 100 tablet2021-08-260000-00-00NoNoCurrent