FDA.reportPublic FDA data

Doxazosin

Product NDC
23155-092
11-digit product format
231550092
Labeler code
23155
Product ID
23155-092_cf1c14bc-a5cc-4800-9ec8-d5fbe267c43c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA205210
Marketing category
ANDA
Marketing start
2018-02-13
Substance
DOXAZOSIN MESYLATE
Active strength
1 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

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
A205210-001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-13
A205210-002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-13
A205210-003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-13
A205210-004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205210-001AB
A205210-002AB
A205210-003AB
A205210-004AB

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 22:54:322026-06A205210-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-02-13a50c72e98297…
2026-08-01 22:54:322026-06A205210-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-02-13a50c72e98297…
2026-08-01 22:54:322026-06A205210-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-02-13a50c72e98297…
2026-08-01 22:54:322026-06A205210-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-02-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205210-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205210-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A205210-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A205210-004AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxazosinDOXAZOSINGolden State Medical Supply, Inc.54eeef3d-c906-37e7-e063-6294a90afca22026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205210
application number: ANDA205210
DoxazosinDOXAZOSINHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.7991373e-8a62-47f9-b4fb-90573485af4e2024-07-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205210
application number: ANDA205210
ndc (product): 23155-092

Additional Listing Data#

Finished product
Yes
Brand name base
Doxazosin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86P6PQK0MUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197625Internal RxNorm lookup
197626Internal RxNorm lookup
197627Internal RxNorm lookup
197628Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7991373e-8a62-47f9-b4fb-90573485af4eAvailable on FDA.report

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
23155-092-012020-08-05C16284748780-19d75b9d0-3dd5-f424-e053-dadaa90a57ceThese 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
23155-092-012020-01-31C16284748780-19d75b9d0-3dd5-f424-e053-dadaa90a57ceThese 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
23155-092-01Doxazosin100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-092-01EA - Each23155-092b0537b97-47c5-4deb-b1cc-cff18027c33512019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-092DOXAZOSIN TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 1 package rows20240705_7991373e-8a62-47f9-b4fb-90573485af4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSN7991373e-8a62-47f9-b4fb-90573485af4e9
197626doxazosin mesylate 2 MG Oral TabletPSN7991373e-8a62-47f9-b4fb-90573485af4e9
197627doxazosin mesylate 4 MG Oral TabletPSN7991373e-8a62-47f9-b4fb-90573485af4e9
197628doxazosin mesylate 8 MG Oral TabletPSN7991373e-8a62-47f9-b4fb-90573485af4e9
197625doxazosin 1 MG Oral TabletSCD7991373e-8a62-47f9-b4fb-90573485af4e9
197626doxazosin 2 MG Oral TabletSCD7991373e-8a62-47f9-b4fb-90573485af4e9
197627doxazosin 4 MG Oral TabletSCD7991373e-8a62-47f9-b4fb-90573485af4e9
197628doxazosin 8 MG Oral TabletSCD7991373e-8a62-47f9-b4fb-90573485af4e9
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY7991373e-8a62-47f9-b4fb-90573485af4e9
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY7991373e-8a62-47f9-b4fb-90573485af4e9
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY7991373e-8a62-47f9-b4fb-90573485af4e9
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY7991373e-8a62-47f9-b4fb-90573485af4e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-092-0123155009201100 TABLET in 1 BOTTLE (23155-092-01) 100 tablet2018-02-130000-00-00NoNoCurrent