Doxazosin

Product NDC
71335-0309
11-digit product format
713350309
Labeler code
71335
Product ID
71335-0309_b8f7253a-3e90-4663-be31-22d8be29f2a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202824
Marketing category
ANDA
Marketing start
2017-06-14
Substance
DOXAZOSIN MESYLATE
Active strength
2 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 42.

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202824-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A202824-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A202824-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A202824-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-11caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202824-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202824-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202824-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202824-004AB1caaa826d4ba7…
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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE2 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
197626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef8b5534-5939-400a-ad5e-f9ceaefc4097Available 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
71335-0309-1Doxazosin30 in 1 BOTTLETABLET307
71335-0309-2Doxazosin60 in 1 BOTTLETABLET607
71335-0309-3Doxazosin90 in 1 BOTTLETABLET907
71335-0309-4Doxazosin28 in 1 BOTTLETABLET287
71335-0309-5Doxazosin18 in 1 BOTTLETABLET187

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0309-1EA - Each71335-03097a565fba-9bdd-49fc-9771-46380a93904a12018-09-05
71335-0309-3EA - Each71335-0309516feffd-51fc-4f61-b353-dfd3939ef0b312018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0309DOXAZOSIN TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 5 package rows20240913_ef8b5534-5939-400a-ad5e-f9ceaefc4097.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
ndc (product): 71335-0309
DoxazosinDOXAZOSINBryant Ranch Prepackac4cd22b-2a03-47b6-9eed-550be278f17d2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202824
application number: ANDA202824
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
197626doxazosin mesylate 2 MG Oral TabletPSNef8b5534-5939-400a-ad5e-f9ceaefc40977
197626doxazosin 2 MG Oral TabletSCDef8b5534-5939-400a-ad5e-f9ceaefc40977
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYef8b5534-5939-400a-ad5e-f9ceaefc40977

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0309-17133503090130 TABLET in 1 BOTTLE (71335-0309-1) 30 tablet2018-07-030000-00-00NoNoCurrent
71335-0309-27133503090260 TABLET in 1 BOTTLE (71335-0309-2) 60 tablet2022-01-270000-00-00NoNoCurrent
71335-0309-37133503090390 TABLET in 1 BOTTLE (71335-0309-3) 90 tablet2018-05-030000-00-00NoNoCurrent
71335-0309-47133503090428 TABLET in 1 BOTTLE (71335-0309-4) 28 tablet2024-09-050000-00-00NoNoCurrent
71335-0309-57133503090518 TABLET in 1 BOTTLE (71335-0309-5) 18 tablet2024-09-050000-00-00NoNoCurrent