Doxazosin

Product NDC
0832-1359
11-digit product format
008321359
Labeler code
0832
Product ID
0832-1359_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
8 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
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
A209013-001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-04-17
A209013-002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-04-17
A209013-003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-04-17
A209013-004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209013-001AB
A209013-002AB
A209013-003AB
A209013-004AB

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 UTC2026-02A209013-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209013-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209013-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209013-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209013-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209013-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209013-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209013-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209013-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209013-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209013-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209013-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209013-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209013-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209013-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209013-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209013-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209013-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209013-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209013-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209013-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209013-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209013-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209013-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209013-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209013-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209013-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209013-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209013-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209013-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209013-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209013-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209013-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209013-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209013-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209013-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209013-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2018-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A209013-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2018-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A209013-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2018-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A209013-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2018-04-17d06236e962d9…

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 UTC2026-02A209013-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209013-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209013-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209013-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209013-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209013-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209013-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209013-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209013-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209013-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209013-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209013-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209013-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209013-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209013-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209013-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209013-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209013-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209013-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209013-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209013-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209013-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209013-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209013-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209013-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209013-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209013-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209013-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209013-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209013-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209013-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209013-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209013-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209013-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209013-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209013-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209013-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209013-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209013-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209013-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Doxazosin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE8 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
b5d1c604-ce3b-4973-845f-9db267a945cdAvailable 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-1359-11Doxazosin100 in 1 BOTTLETABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-1359-11EA - Each0832-135968a9a7f5-fbfa-4eb4-a2d5-181458f7d1cb12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-1359DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [UPSHER-SMITH LABORATORIES, LLC]7Current NDC, Legacy NDC, 1 package rows20230519_b5d1c604-ce3b-4973-845f-9db267a945cd.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxazosinDOXAZOSIN MESYLATEBryant Ranch Prepack277c3278-4fe2-47ac-9115-15b417325ffd2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209013
application number: ANDA209013
DoxazosinDOXAZOSIN MESYLATENorthwind Health Company, LLCf6c9856e-9154-f349-e053-6294a90a9f2c2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209013
application number: ANDA209013
DoxazosinDOXAZOSIN MESYLATEUpsher-Smith laboratories, LLCb5d1c604-ce3b-4973-845f-9db267a945cd2025-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209013
application number: ANDA209013
ndc (product): 0832-1359
DoxazosinDOXAZOSIN MESYLATEA-S Medication Solutionsb4c974ad-cbd6-4811-ab48-461e7ffa99f72025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209013
application number: ANDA209013
DoxazosinDOXAZOSIN MESYLATEAphena Pharma Solutions - Tennessee, LLC0d9df8e9-f823-4ff8-a5fe-0309dd132b042024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209013
application number: ANDA209013
DoxazosinDOXAZOSIN MESYLATEAphena Pharma Solutions - Tennessee, LLC6b74b18f-b89a-4109-a29e-c4fa65a3c5ee2020-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209013
application number: ANDA209013

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
0832-1359-1100832135911100 TABLET in 1 BOTTLE (0832-1359-11) 100 tablet2018-04-172027-01-31NoNoCurrent