Doxazosin

Product NDC
68788-8412
11-digit product format
687888412
Labeler code
68788
Product ID
68788-8412_20678ec9-2943-4e9c-8a7c-86c6ca5335e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075580
Marketing category
ANDA
Marketing start
2023-04-06
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
2027-12-31
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
A075580-001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-18
A075580-002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-18
A075580-003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-18
A075580-004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075580-001AB
A075580-002AB
A075580-003AB
A075580-004AB

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 UTC2026-02A075580-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075580-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075580-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075580-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075580-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075580-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075580-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075580-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075580-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075580-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075580-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075580-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075580-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075580-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075580-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075580-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075580-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075580-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075580-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075580-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075580-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075580-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075580-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075580-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075580-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075580-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075580-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075580-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075580-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075580-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075580-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075580-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075580-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075580-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075580-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075580-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075580-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075580-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075580-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075580-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-18d06236e962d9…

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 UTC2026-02A075580-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075580-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075580-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075580-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075580-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075580-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075580-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075580-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075580-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075580-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075580-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075580-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075580-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075580-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075580-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075580-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075580-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075580-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075580-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075580-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075580-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075580-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075580-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075580-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075580-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075580-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075580-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075580-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075580-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075580-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075580-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075580-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075580-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075580-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075580-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075580-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075580-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075580-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075580-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075580-004AB1d06236e962d9…

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxazosinDOXAZOSINA-S Medication Solutionsbfea0b5b-9354-490f-88ff-008134077d242026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINREMEDYREPACK INC.bf2f7b41-f14d-4fcd-8db3-f507ca6ff78b2026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINPD-Rx Pharmaceuticals, Inc.2ea9bb6b-a4f0-496a-b27b-4454167a4b702026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINCardinal Health 107, LLC08521333-ff21-45ad-b99e-1f43d945d24d2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINREMEDYREPACK INC.30a6bb83-f91b-4c4f-a849-4f2be3735a0e2026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINPreferred Pharmaceuticals Inc.2110eec5-949d-4718-ad6d-3629e5db8a072026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
ndc (product): 68788-8412
DoxazosinDOXAZOSINPreferred Pharmaceuticals Inc.e046e0b7-f510-4318-9884-034d683864d42026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINAvPAKde9ab9a4-d8b8-8b36-e053-2a95a90aaa352026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINAvKAREe3d381c1-3b2f-af70-f4e6-08d6202eed252026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINNuCare Pharmaceuticals, Inc.54116886-ea5e-5320-e054-00144ff8d46c2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINBryant Ranch Prepack54549d19-6311-4dbb-8622-fd3e5440551a2026-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINNorthwind Health Company, LLCf306adae-a2fe-5477-e053-2995a90a78382026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINAmerican Health Packaging3f4dc1a7-05e6-41d7-908c-30ce2677d87b2025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINApotex Corp.4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b2025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINMajor Pharmaceuticals3354196f-bbcf-4bc5-94f6-e6e8e132acb12025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINAphena Pharma Solutions - Tennessee, LLC2e5cd8cb-7d43-e7af-e063-6294a90a310e2025-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINNuCare Pharmaceuticals, Inc.505d3c4c-5506-72cc-e054-00144ff88e882024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINProficient Rx LP1d8ff659-8129-4dca-9e8f-13b97240d1e12024-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINAphena Pharma Solutions - Tennessee, LLCf1dc70f6-4329-46da-8990-7bd6eec9d37d2021-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINAphena Pharma Solutions - Tennessee, LLC7e547752-a53a-4ad9-b70e-7cc2a1dd5d5d2018-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580

Additional Listing Data#

Finished product
Yes
Brand name base
Doxazosin
Listing expiration
2027-12-31

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
2110eec5-949d-4718-ad6d-3629e5db8a07Available 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
68788-8412-1Doxazosin100 in 1 BOTTLETABLET1004
68788-8412-3Doxazosin30 in 1 BOTTLETABLET304
68788-8412-6Doxazosin60 in 1 BOTTLETABLET604
68788-8412-9Doxazosin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8412-1EA - Each68788-8412e58a2b5b-6356-4fbd-abed-ee24c9f8bc4312023-06-06
68788-8412-3EA - Each68788-84123eddd3e7-3f5b-4a6a-962f-a0ae0e23417112023-06-06
68788-8412-6EA - Each68788-841265046aeb-8788-41cc-85b8-98ccb51946d012023-06-06
68788-8412-9EA - Each68788-8412bc6eecee-9e63-4e45-90bd-8dc220e46bc412023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8412DOXAZOSIN TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250406_2110eec5-949d-4718-ad6d-3629e5db8a07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197627doxazosin mesylate 4 MG Oral TabletPSN2110eec5-949d-4718-ad6d-3629e5db8a074
197627doxazosin 4 MG Oral TabletSCD2110eec5-949d-4718-ad6d-3629e5db8a074
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY2110eec5-949d-4718-ad6d-3629e5db8a074

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8412-168788841201100 TABLET in 1 BOTTLE (68788-8412-1) 100 tablet2023-04-06NoNoCurrent
68788-8412-36878884120330 TABLET in 1 BOTTLE (68788-8412-3) 30 tablet2023-04-06NoNoCurrent
68788-8412-66878884120660 TABLET in 1 BOTTLE (68788-8412-6) 60 tablet2023-04-06NoNoCurrent
68788-8412-96878884120990 TABLET in 1 BOTTLE (68788-8412-9) 90 tablet2023-04-06NoNoCurrent