Doxazosin

Product NDC
71335-0349
Requested package NDC
71335-0349-4
11-digit product format
713350349
Labeler code
71335
Product ID
71335-0349_df1e5ab6-5900-4fbe-a448-f5da91047d1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-034971335-0349-4DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A202824-001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-11
A202824-002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-11
A202824-003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-11
A202824-004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202824-001AB
A202824-002AB
A202824-003AB
A202824-004AB

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202824-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202824-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202824-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202824-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202824-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202824-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202824-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202824-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202824-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202824-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202824-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202824-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202824-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202824-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202824-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202824-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202824-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202824-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202824-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202824-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202824-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202824-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202824-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202824-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202824-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202824-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202824-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202824-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202824-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202824-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202824-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202824-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202824-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202824-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202824-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202824-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202824-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202824-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202824-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202824-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-11d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202824-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202824-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202824-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202824-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202824-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202824-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202824-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202824-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202824-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202824-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202824-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202824-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202824-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202824-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202824-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202824-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202824-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202824-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202824-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202824-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202824-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202824-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202824-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202824-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202824-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202824-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202824-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202824-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202824-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202824-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202824-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202824-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202824-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202824-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202824-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202824-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202824-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202824-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202824-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202824-004AB1d06236e962d9…

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 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac4cd22b-2a03-47b6-9eed-550be278f17dAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0349-1Doxazosin100 in 1 BOTTLETABLET100102
71335-0349-2Doxazosin30 in 1 BOTTLETABLET30102
71335-0349-3Doxazosin60 in 1 BOTTLETABLET60102
71335-0349-4Doxazosin90 in 1 BOTTLETABLET90102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0349DOXAZOSIN TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 4 package rows20240913_ac4cd22b-2a03-47b6-9eed-550be278f17d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxazosinDOXAZOSINREMEDYREPACK INC.71815e8f-33ed-4f36-a8ec-d4443151a9d82026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
DoxazosinDOXAZOSINNorthwind Health Company, LLCf2b35586-d550-3fcb-e053-2995a90a34032026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
DOXAZOSINDOXAZOSINdirect rxb57cf33b-e0bd-54e9-e053-2a95a90a5a6a2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
DoxazosinDOXAZOSINBryant Ranch Prepack8c0c0345-833b-4a3d-9081-da66b208d7502024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
DoxazosinDOXAZOSINBryant Ranch Prepackef8b5534-5939-400a-ad5e-f9ceaefc40972024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
DoxazosinDOXAZOSINBryant Ranch Prepackac4cd22b-2a03-47b6-9eed-550be278f17d2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
ndc (package): 71335-0349-4
ndc (product): 71335-0349
ndc11 (package): 71335034904
DoxazosinDOXAZOSINAccord Healthcare Inc.2830533c-ccdf-4401-b19c-763eeb1bc0a72024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
DoxazosinDOXAZOSINNuCare Pharmaceuticals, Inc.40e47e75-6a47-323b-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
DoxazosinDOXAZOSINA-S Medication Solutions4034fb6d-f55d-4df0-b500-d6a413591f6e2024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
DoxazosinDOXAZOSINA-S Medication Solutions9f67fa58-f623-4145-9e2c-98feee7ca45f2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
DoxazosinDOXAZOSINNuCare Pharmaceuticals,Inc.64a243e6-7056-115d-e053-2a91aa0a510f2024-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
DoxazosinDOXAZOSINNuCare Pharmaceuticals,Inc.64a19cb1-79fc-8b0b-e053-2a91aa0aaa942024-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
DoxazosinDOXAZOSINProficient Rx LP8de7d5ee-7f9d-447a-af76-7a7fbf3eb33d2022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0349-47133503490490 TABLET in 1 BOTTLE (71335-0349-4) 90 tablet2018-05-030000-00-00NoNoCurrent