Doxazosin

Product NDC
71610-878
Requested package NDC
71610-878-80
11-digit product format
716100878
Labeler code
71610
Product ID
71610-878_2e5cd8d6-54c4-e3b5-e063-6294a90abe5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075580
Marketing category
ANDA
Marketing start
2011-07-14
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075580-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-1884e616aacf4f…
2026-09-14 22:38:342026-08A075580-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-1884e616aacf4f…
2026-09-14 22:38:342026-08A075580-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-1884e616aacf4f…
2026-09-14 22:38:342026-08A075580-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-1884e616aacf4f…
2026-08-18 06:07:402026-07A075580-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2000-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07A075580-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2000-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07A075580-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2000-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07A075580-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2000-10-18caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075580-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075580-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A075580-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A075580-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A075580-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075580-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075580-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075580-004AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
2e5cd8cb-7d43-e7af-e063-6294a90a310eAvailable 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
71610-878-60Doxazosin90 in 1 BOTTLETABLET901
71610-878-80Doxazosin180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-878-60EA - Each71610-878c1a366ff-6dde-4141-9fbf-d1e44cbeea1112025-05-14
71610-878-80EA - Each71610-878596b0b13-4afe-4cda-bcdc-4ad1bc1a2c4112025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-878DOXAZOSIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 2 package rows20250221_2e5cd8cb-7d43-e7af-e063-6294a90a310e.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxazosinDOXAZOSINREMEDYREPACK INC.30a6bb83-f91b-4c4f-a849-4f2be3735a0e2026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
DoxazosinDOXAZOSINMajor Pharmaceuticals3354196f-bbcf-4bc5-94f6-e6e8e132acb12026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
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
DoxazosinDOXAZOSINPreferred Pharmaceuticals Inc.2110eec5-949d-4718-ad6d-3629e5db8a072026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
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
DoxazosinDOXAZOSINAphena Pharma Solutions - Tennessee, LLC2e5cd8cb-7d43-e7af-e063-6294a90a310e2025-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075580
application number: ANDA075580
ndc (package): 71610-878-80
ndc (product): 71610-878
ndc11 (package): 71610087880
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197628doxazosin mesylate 8 MG Oral TabletPSN2e5cd8cb-7d43-e7af-e063-6294a90a310e1
197628doxazosin 8 MG Oral TabletSCD2e5cd8cb-7d43-e7af-e063-6294a90a310e1
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY2e5cd8cb-7d43-e7af-e063-6294a90a310e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-878-8071610087880180 TABLET in 1 BOTTLE (71610-878-80) 180 tablet2025-02-13NoNoCurrent