Doxazosin

Product NDC
16729-415
11-digit product format
167290415
Labeler code
16729
Product ID
16729-415_1fbdaa94-b68a-b934-e063-6294a90a8b77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202824
Marketing category
ANDA
Marketing start
2017-07-10
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 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…

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 · 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
2830533c-ccdf-4401-b19c-763eeb1bc0a7Available 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
16729-415-01Doxazosin100 in 1 BOTTLETABLET10011
16729-415-17Doxazosin1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-415-01EA - Each16729-415e87518d1-8f71-483d-8e36-a42f5815c19912017-08-11
16729-415-17EA - Each16729-41564cceaf3-959b-4aee-b534-aace46b788ab12017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-415DOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]11Current NDC, Legacy NDC, 2 package rows20240816_2830533c-ccdf-4401-b19c-763eeb1bc0a7.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
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
ndc (product): 16729-415
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
197625doxazosin mesylate 1 MG Oral TabletPSN2830533c-ccdf-4401-b19c-763eeb1bc0a711
197626doxazosin mesylate 2 MG Oral TabletPSN2830533c-ccdf-4401-b19c-763eeb1bc0a711
197627doxazosin mesylate 4 MG Oral TabletPSN2830533c-ccdf-4401-b19c-763eeb1bc0a711
197628doxazosin mesylate 8 MG Oral TabletPSN2830533c-ccdf-4401-b19c-763eeb1bc0a711
197625doxazosin 1 MG Oral TabletSCD2830533c-ccdf-4401-b19c-763eeb1bc0a711
197626doxazosin 2 MG Oral TabletSCD2830533c-ccdf-4401-b19c-763eeb1bc0a711
197627doxazosin 4 MG Oral TabletSCD2830533c-ccdf-4401-b19c-763eeb1bc0a711
197628doxazosin 8 MG Oral TabletSCD2830533c-ccdf-4401-b19c-763eeb1bc0a711
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY2830533c-ccdf-4401-b19c-763eeb1bc0a711
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY2830533c-ccdf-4401-b19c-763eeb1bc0a711
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY2830533c-ccdf-4401-b19c-763eeb1bc0a711
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY2830533c-ccdf-4401-b19c-763eeb1bc0a711
197627doxazosin mesylate 4 MG Oral TabletPSN8d40679a-d0cd-39b1-e053-2995a90a40852
197628doxazosin mesylate 8 MG Oral TabletPSN8d40679a-d0cd-39b1-e053-2995a90a40852
197627doxazosin 4 MG Oral TabletSCD8d40679a-d0cd-39b1-e053-2995a90a40852
197628doxazosin 8 MG Oral TabletSCD8d40679a-d0cd-39b1-e053-2995a90a40852
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY8d40679a-d0cd-39b1-e053-2995a90a40852
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY8d40679a-d0cd-39b1-e053-2995a90a40852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-415-0116729041501100 TABLET in 1 BOTTLE (16729-415-01) 100 tablet2017-07-100000-00-00NoNoCurrent
16729-415-17167290415171000 TABLET in 1 BOTTLE (16729-415-17) 1000 tablet2017-07-100000-00-00NoNoCurrent