FDA.reportPublic FDA data

Cardura

Product NDC
0049-2410
Requested package NDC
0049-2410-10
11-digit product format
000492410
Labeler code
0049
Product ID
0049-2410_aded71a7-bfc7-4006-8378-578776e7bfd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Roerig
Application
NDA019668
Marketing category
NDA
Marketing start
2021-10-19
Marketing end
0000-00-00
Substance
DOXAZOSIN MESYLATE
Active strength
1 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0049-24100049-2410-10DDiscontinued by firm2026-08-03

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
N019668-001CARDURADOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02
N019668-002CARDURADOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALABRLD1990-11-02
N019668-003CARDURADOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALABRLD1990-11-02
N019668-004CARDURADOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALABRLD1990-11-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N019668-001AB
N019668-002AB
N019668-003AB
N019668-004AB

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 22:54:322026-06N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02a50c72e98297…
2026-08-01 22:54:322026-06N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-02a50c72e98297…
2026-08-01 22:54:322026-06N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-02a50c72e98297…
2026-08-01 22:54:322026-06N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N019668-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N019668-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N019668-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N019668-004AB1a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxazosin mesylateDOXAZOSIN MESYLATEAphena Pharma Solutions - Tennessee, LLC445dc831-1960-4b25-e063-6294a90a6efd2025-11-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
DoxazosinDOXAZOSINAphena Pharma Solutions - Tennessee, LLC3ab222b7-74cc-5343-e063-6294a90a96162025-07-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
Doxazosin mesylateDOXAZOSIN MESYLATEMylan Pharmaceuticals Inc.2e524986-7903-416f-b2b8-d27295103e752024-03-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
CarduraDOXAZOSINViatris Specialty LLC5e1f5e49-2da1-43ab-9795-228a8bcc5a822023-10-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
DoxazosinDOXAZOSINAphena Pharma Solutions - Tennessee, LLCb364c7a8-72b5-4776-a500-400c37a72c9b2022-02-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
DoxazosinDOXAZOSINMylan Pharmaceuticals Inc.6b887aa5-5edf-48c5-a480-dea8c35afa9d2022-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
CarduraDOXAZOSINROERIGeefc47bc-c10f-49bb-8ef7-5999f798ab392022-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
ndc (package): 0049-2410-10
ndc (product): 0049-2410
ndc11 (package): 00049241010

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
0049-2410-10Cardura100 in 1 BOTTLETABLET10025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-2410-10EA - Each0049-2410ccfca243-89e2-4e88-a5ae-a6b745f5ca9412021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUCARDURA (DOXAZOSIN MESYLATE) TABLET [ROERIG]8
DOXAZOSINACTIVE MOIETYNW1291F1W8CARDURA (DOXAZOSIN MESYLATE) TABLET [ROERIG]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARDURA (DOXAZOSIN MESYLATE) TABLET [ROERIG]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCARDURA (DOXAZOSIN MESYLATE) TABLET [ROERIG]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CARDURA (DOXAZOSIN MESYLATE) TABLET [ROERIG]8
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCARDURA (DOXAZOSIN MESYLATE) TABLET [ROERIG]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARDURA (DOXAZOSIN MESYLATE) TABLET [ROERIG]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARDURA (DOXAZOSIN MESYLATE) TABLET [ROERIG]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARDURA (DOXAZOSIN MESYLATE) TABLET [ROERIG]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-2410CARDURA (DOXAZOSIN MESYLATE) TABLET CARDURA (DOXAZOSIN) TABLET [ROERIG]24Legacy NDC, 1 package rows20250425_eefc47bc-c10f-49bb-8ef7-5999f798ab39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104367Cardura 1 MG Oral TabletPSNeefc47bc-c10f-49bb-8ef7-5999f798ab3925
104368Cardura 2 MG Oral TabletPSNeefc47bc-c10f-49bb-8ef7-5999f798ab3925
104369Cardura 4 MG Oral TabletPSNeefc47bc-c10f-49bb-8ef7-5999f798ab3925
205544Cardura 8 MG Oral TabletPSNeefc47bc-c10f-49bb-8ef7-5999f798ab3925
197625doxazosin mesylate 1 MG Oral TabletPSNeefc47bc-c10f-49bb-8ef7-5999f798ab3925
197626doxazosin mesylate 2 MG Oral TabletPSNeefc47bc-c10f-49bb-8ef7-5999f798ab3925
197627doxazosin mesylate 4 MG Oral TabletPSNeefc47bc-c10f-49bb-8ef7-5999f798ab3925
197628doxazosin mesylate 8 MG Oral TabletPSNeefc47bc-c10f-49bb-8ef7-5999f798ab3925
104367doxazosin 1 MG Oral Tablet [Cardura]SBDeefc47bc-c10f-49bb-8ef7-5999f798ab3925
104368doxazosin 2 MG Oral Tablet [Cardura]SBDeefc47bc-c10f-49bb-8ef7-5999f798ab3925
104369doxazosin 4 MG Oral Tablet [Cardura]SBDeefc47bc-c10f-49bb-8ef7-5999f798ab3925
205544doxazosin 8 MG Oral Tablet [Cardura]SBDeefc47bc-c10f-49bb-8ef7-5999f798ab3925
197625doxazosin 1 MG Oral TabletSCDeefc47bc-c10f-49bb-8ef7-5999f798ab3925
197626doxazosin 2 MG Oral TabletSCDeefc47bc-c10f-49bb-8ef7-5999f798ab3925
197627doxazosin 4 MG Oral TabletSCDeefc47bc-c10f-49bb-8ef7-5999f798ab3925
197628doxazosin 8 MG Oral TabletSCDeefc47bc-c10f-49bb-8ef7-5999f798ab3925
104367Cardura (as doxazosin mesylate) 1 MG Oral TabletSYeefc47bc-c10f-49bb-8ef7-5999f798ab3925
104368Cardura (as doxazosin mesylate) 2 MG Oral TabletSYeefc47bc-c10f-49bb-8ef7-5999f798ab3925
205544Cardura (as doxazosin mesylate) 8 MG Oral TabletSYeefc47bc-c10f-49bb-8ef7-5999f798ab3925
104367Cardura 1 MG Oral TabletSYeefc47bc-c10f-49bb-8ef7-5999f798ab3925
104368Cardura 2 MG Oral TabletSYeefc47bc-c10f-49bb-8ef7-5999f798ab3925
104369Cardura 4 MG (as doxazosin mesylate) Oral TabletSYeefc47bc-c10f-49bb-8ef7-5999f798ab3925
104369Cardura 4 MG Oral TabletSYeefc47bc-c10f-49bb-8ef7-5999f798ab3925
205544Cardura 8 MG Oral TabletSYeefc47bc-c10f-49bb-8ef7-5999f798ab3925
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSYeefc47bc-c10f-49bb-8ef7-5999f798ab3925
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYeefc47bc-c10f-49bb-8ef7-5999f798ab3925
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYeefc47bc-c10f-49bb-8ef7-5999f798ab3925
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYeefc47bc-c10f-49bb-8ef7-5999f798ab3925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-2410-1000049241010100 TABLET in 1 BOTTLE (0049-2410-10) 100 tablet2021-10-190000-00-00NoNoCurrent