FDA.reportPublic FDA data

Cardura

Product NDC
58151-078
11-digit product format
581510078
Labeler code
58151
Product ID
58151-078_7fe31b0a-4fb2-427f-83e2-d5b957d6738b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxazosin mesylate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA021269
Marketing category
NDA
Marketing start
2024-04-23
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

Additional Listing Data#

Finished product
Yes
Brand name base
Cardura
Brand name suffix
XL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86P6PQK0MU
Rxcui636360, 636361, 1242404, 1242408

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
58151-078-93CarduraXL30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-078-93EA - Each58151-078b30e1036-1f0d-4c2a-be00-cd22a9e4e27012024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-078CARDURA XL (DOXAZOSIN MESYLATE) TABLET, FILM COATED, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]2Current NDC, 1 package rows20240425_355bcdce-0481-48ba-8ebd-2009106aaf77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1242404Cardura XL 4 MG 24HR Extended Release Oral TabletPSN355bcdce-0481-48ba-8ebd-2009106aaf772
1242408Cardura XL 8 MG 24HR Extended Release Oral TabletPSN355bcdce-0481-48ba-8ebd-2009106aaf772
636360doxazosin mesylate 4 MG 24HR Extended Release Oral TabletPSN355bcdce-0481-48ba-8ebd-2009106aaf772
636361doxazosin mesylate 8 MG 24HR Extended Release Oral TabletPSN355bcdce-0481-48ba-8ebd-2009106aaf772
124240424 HR doxazosin 4 MG Extended Release Oral Tablet [Cardura]SBD355bcdce-0481-48ba-8ebd-2009106aaf772
124240824 HR doxazosin 8 MG Extended Release Oral Tablet [Cardura]SBD355bcdce-0481-48ba-8ebd-2009106aaf772
63636024 HR doxazosin 4 MG Extended Release Oral TabletSCD355bcdce-0481-48ba-8ebd-2009106aaf772
63636124 HR doxazosin 8 MG Extended Release Oral TabletSCD355bcdce-0481-48ba-8ebd-2009106aaf772
124240424 HR Cardura 4 MG Extended Release Oral TabletSY355bcdce-0481-48ba-8ebd-2009106aaf772
124240824 HR Cardura 8 MG Extended Release Oral TabletSY355bcdce-0481-48ba-8ebd-2009106aaf772
1242404Cardura XL 4 MG (as doxazosin mesylate 5.1 MG) 24 HR Extended Release Oral TabletSY355bcdce-0481-48ba-8ebd-2009106aaf772
1242404Cardura XL 4 MG 24 HR Extended Release Oral TabletSY355bcdce-0481-48ba-8ebd-2009106aaf772
1242408Cardura XL 8 MG (as doxazosin mesylate 10.2 MG) 24 HR Extended Release Oral TabletSY355bcdce-0481-48ba-8ebd-2009106aaf772
1242408Cardura XL 8 MG 24 HR Extended Release Oral TabletSY355bcdce-0481-48ba-8ebd-2009106aaf772
636360doxazosin (as doxazosin mesylate) 4 MG 24 HR Extended Release Oral TabletSY355bcdce-0481-48ba-8ebd-2009106aaf772
636361doxazosin (as doxazosin mesylate) 8 MG 24 HR Extended Release Oral TabletSY355bcdce-0481-48ba-8ebd-2009106aaf772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58151-078-935815100789330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-078-93) 2024-04-23NoNoCurrent