Cardura

Product NDC
0049-2716
11-digit product format
000492716
Labeler code
0049
Product ID
0049-2716_82ce1cc2-6905-465d-9a2a-9f2415af59a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
ROERIG
Application
NDA019668
Marketing category
NDA
Marketing start
2023-02-15
Marketing end
2027-06-30
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
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.

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 UTC2026-02N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-02d06236e962d9…

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 UTC2026-02N019668-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019668-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019668-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019668-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019668-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019668-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019668-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019668-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019668-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019668-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019668-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019668-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Cardura

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 · 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
eefc47bc-c10f-49bb-8ef7-5999f798ab39Available 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
0049-2716-10Cardura100 in 1 BOTTLETABLET10025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-2716-10EA - Each0049-2716523db8b9-9bbc-4671-8b83-7af34eca2ccf12023-03-13

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
0049-2716CARDURA (DOXAZOSIN MESYLATE) TABLET CARDURA (DOXAZOSIN) TABLET [ROERIG]24Current NDC, 1 package rows20250425_eefc47bc-c10f-49bb-8ef7-5999f798ab39.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 · 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 (product): 0049-2716

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
0049-2716-1000049271610100 TABLET in 1 BOTTLE (0049-2716-10) 100 tablet2023-02-152027-06-30NoNoHistorical