FDA.reportPublic FDA data

Doxazosin

Product NDC
16729-213
11-digit product format
167290213
Labeler code
16729
Product ID
16729-213_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
2015-04-22
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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202824-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2014-06-11a50c72e98297…
2026-08-01 22:54:322026-06A202824-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2014-06-11a50c72e98297…
2026-08-01 22:54:322026-06A202824-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2014-06-11a50c72e98297…
2026-08-01 22:54:322026-06A202824-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2014-06-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202824-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202824-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202824-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A202824-004AB1a50c72e98297…

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
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): 16729-213
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 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 · 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
16729-213-01Doxazosin100 in 1 BOTTLETABLET10011
16729-213-17Doxazosin1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-213-01EA - Each16729-213a3ff3801-0958-49e2-aec0-8a39b8162e2912015-04-03
16729-213-17EA - Each16729-213f5504b45-e2cd-4007-b342-b10c4192a2af12015-04-03

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
16729-213DOXAZOSIN TABLET [ACCORD HEALTHCARE INC.]11Current NDC, Legacy NDC, 2 package rows20240816_2830533c-ccdf-4401-b19c-763eeb1bc0a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197627doxazosin mesylate 4 MG Oral TabletPSNac4cd22b-2a03-47b6-9eed-550be278f17d102
197627doxazosin 4 MG Oral TabletSCDac4cd22b-2a03-47b6-9eed-550be278f17d102
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYac4cd22b-2a03-47b6-9eed-550be278f17d102
197625doxazosin mesylate 1 MG Oral TabletPSN4034fb6d-f55d-4df0-b500-d6a413591f6e43
197626doxazosin mesylate 2 MG Oral TabletPSN4034fb6d-f55d-4df0-b500-d6a413591f6e43
197627doxazosin mesylate 4 MG Oral TabletPSN4034fb6d-f55d-4df0-b500-d6a413591f6e43
197628doxazosin mesylate 8 MG Oral TabletPSN4034fb6d-f55d-4df0-b500-d6a413591f6e43
197625doxazosin 1 MG Oral TabletSCD4034fb6d-f55d-4df0-b500-d6a413591f6e43
197626doxazosin 2 MG Oral TabletSCD4034fb6d-f55d-4df0-b500-d6a413591f6e43
197627doxazosin 4 MG Oral TabletSCD4034fb6d-f55d-4df0-b500-d6a413591f6e43
197628doxazosin 8 MG Oral TabletSCD4034fb6d-f55d-4df0-b500-d6a413591f6e43
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY4034fb6d-f55d-4df0-b500-d6a413591f6e43
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY4034fb6d-f55d-4df0-b500-d6a413591f6e43
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY4034fb6d-f55d-4df0-b500-d6a413591f6e43
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY4034fb6d-f55d-4df0-b500-d6a413591f6e43
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 TabletPSN40e47e75-6a47-323b-e054-00144ff8d46c6
197627doxazosin 4 MG Oral TabletSCD40e47e75-6a47-323b-e054-00144ff8d46c6
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY40e47e75-6a47-323b-e054-00144ff8d46c6
197627doxazosin mesylate 4 MG Oral TabletPSNf2b35586-d550-3fcb-e053-2995a90a34035
197627doxazosin 4 MG Oral TabletSCDf2b35586-d550-3fcb-e053-2995a90a34035
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYf2b35586-d550-3fcb-e053-2995a90a34035
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
197627doxazosin mesylate 4 MG Oral TabletPSN8de7d5ee-7f9d-447a-af76-7a7fbf3eb33d1
197627doxazosin 4 MG Oral TabletSCD8de7d5ee-7f9d-447a-af76-7a7fbf3eb33d1
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY8de7d5ee-7f9d-447a-af76-7a7fbf3eb33d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-213-0116729021301100 TABLET in 1 BOTTLE (16729-213-01) 100 tablet2015-04-220000-00-00NoNoCurrent
16729-213-17167290213171000 TABLET in 1 BOTTLE (16729-213-17) 1000 tablet2016-07-280000-00-00NoNoCurrent