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 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…

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 · 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

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

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