FDA.reportPublic FDA data

Cardura

Product NDC
58151-075
11-digit product format
581510075
Labeler code
58151
Product ID
58151-075_438349cb-eae0-43b5-b045-d447b1c9a376
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA019668
Marketing category
NDA
Marketing start
2025-04-23
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
2027-12-31
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
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
ndc (product): 58151-075
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

Additional Listing Data#

Finished product
Yes
Brand name base
Cardura
Listing expiration
2027-12-31

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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
104367Internal RxNorm lookup
104368Internal RxNorm lookup
104369Internal RxNorm lookup
197625Internal RxNorm lookup
197626Internal RxNorm lookup
197627Internal RxNorm lookup
197628Internal RxNorm lookup
205544Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e1f5e49-2da1-43ab-9795-228a8bcc5a82Available 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
58151-075-01Cardura100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-075CARDURA (DOXAZOSIN) TABLET [VIATRIS SPECIALTY LLC]1Current NDC, 1 package rows20250425_5e1f5e49-2da1-43ab-9795-228a8bcc5a82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104367Cardura 1 MG Oral TabletPSN5e1f5e49-2da1-43ab-9795-228a8bcc5a822
104368Cardura 2 MG Oral TabletPSN5e1f5e49-2da1-43ab-9795-228a8bcc5a822
104369Cardura 4 MG Oral TabletPSN5e1f5e49-2da1-43ab-9795-228a8bcc5a822
205544Cardura 8 MG Oral TabletPSN5e1f5e49-2da1-43ab-9795-228a8bcc5a822
197625doxazosin mesylate 1 MG Oral TabletPSN5e1f5e49-2da1-43ab-9795-228a8bcc5a822
197626doxazosin mesylate 2 MG Oral TabletPSN5e1f5e49-2da1-43ab-9795-228a8bcc5a822
197627doxazosin mesylate 4 MG Oral TabletPSN5e1f5e49-2da1-43ab-9795-228a8bcc5a822
197628doxazosin mesylate 8 MG Oral TabletPSN5e1f5e49-2da1-43ab-9795-228a8bcc5a822
104367doxazosin 1 MG Oral Tablet [Cardura]SBD5e1f5e49-2da1-43ab-9795-228a8bcc5a822
104368doxazosin 2 MG Oral Tablet [Cardura]SBD5e1f5e49-2da1-43ab-9795-228a8bcc5a822
104369doxazosin 4 MG Oral Tablet [Cardura]SBD5e1f5e49-2da1-43ab-9795-228a8bcc5a822
205544doxazosin 8 MG Oral Tablet [Cardura]SBD5e1f5e49-2da1-43ab-9795-228a8bcc5a822
197625doxazosin 1 MG Oral TabletSCD5e1f5e49-2da1-43ab-9795-228a8bcc5a822
197626doxazosin 2 MG Oral TabletSCD5e1f5e49-2da1-43ab-9795-228a8bcc5a822
197627doxazosin 4 MG Oral TabletSCD5e1f5e49-2da1-43ab-9795-228a8bcc5a822
197628doxazosin 8 MG Oral TabletSCD5e1f5e49-2da1-43ab-9795-228a8bcc5a822
104367Cardura (as doxazosin mesylate) 1 MG Oral TabletSY5e1f5e49-2da1-43ab-9795-228a8bcc5a822
104368Cardura (as doxazosin mesylate) 2 MG Oral TabletSY5e1f5e49-2da1-43ab-9795-228a8bcc5a822
205544Cardura (as doxazosin mesylate) 8 MG Oral TabletSY5e1f5e49-2da1-43ab-9795-228a8bcc5a822
104367Cardura 1 MG Oral TabletSY5e1f5e49-2da1-43ab-9795-228a8bcc5a822
104368Cardura 2 MG Oral TabletSY5e1f5e49-2da1-43ab-9795-228a8bcc5a822
104369Cardura 4 MG (as doxazosin mesylate) Oral TabletSY5e1f5e49-2da1-43ab-9795-228a8bcc5a822
104369Cardura 4 MG Oral TabletSY5e1f5e49-2da1-43ab-9795-228a8bcc5a822
205544Cardura 8 MG Oral TabletSY5e1f5e49-2da1-43ab-9795-228a8bcc5a822
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY5e1f5e49-2da1-43ab-9795-228a8bcc5a822
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY5e1f5e49-2da1-43ab-9795-228a8bcc5a822
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY5e1f5e49-2da1-43ab-9795-228a8bcc5a822
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY5e1f5e49-2da1-43ab-9795-228a8bcc5a822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58151-075-0158151007501100 in 1 BOTTLEHistorical