Cardura

Product NDC
0049-2614
11-digit product format
000492614
Labeler code
0049
Product ID
0049-2614_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
2021-10-19
Marketing end
2027-01-31
Substance
DOXAZOSIN MESYLATE
Active strength
4 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cardura

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86P6PQK0MU
Rxcui104367, 104368, 104369, 197625, 197626, 197627, 197628, 205544

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
0049-2614-10Cardura100 in 1 BOTTLETABLET10025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-2614-10EA - Each0049-261449424e8e-3272-49ef-8bf7-2ccea48dee9a12021-11-09

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
0049-2614CARDURA (DOXAZOSIN MESYLATE) TABLET CARDURA (DOXAZOSIN) TABLET [ROERIG]24Current NDC, Legacy 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
0049-2614-1000049261410100 TABLET in 1 BOTTLE (0049-2614-10) 100 tablet2021-10-192027-01-31NoNoCurrent