FDA.reportPublic FDA data

Doxazosin

Product NDC
0378-4021
11-digit product format
003784021
Labeler code
0378
Product ID
0378-4021_108d973f-0493-4739-82a1-8370d32daa7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxazosin mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075509
Marketing category
ANDA
Marketing start
2000-10-20
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
07a517fc-5845-3816-0f81-0a121804ec9eProduct name620250107
171dd63c-7eea-ede4-c010-4c25ba0a1087Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4021-01EA - Each0378-4021766fe604-20e6-4d16-a97c-025f62d8db0912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXAZOSIN (DOXAZOSIN MESYLATE) TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSN05e29a60-ebf9-470a-b565-40a6f1f6e1022
197626doxazosin mesylate 2 MG Oral TabletPSN05e29a60-ebf9-470a-b565-40a6f1f6e1022
197627doxazosin mesylate 4 MG Oral TabletPSN05e29a60-ebf9-470a-b565-40a6f1f6e1022
197628doxazosin mesylate 8 MG Oral TabletPSN05e29a60-ebf9-470a-b565-40a6f1f6e1022
197625doxazosin 1 MG Oral TabletSCD05e29a60-ebf9-470a-b565-40a6f1f6e1022
197626doxazosin 2 MG Oral TabletSCD05e29a60-ebf9-470a-b565-40a6f1f6e1022
197627doxazosin 4 MG Oral TabletSCD05e29a60-ebf9-470a-b565-40a6f1f6e1022
197628doxazosin 8 MG Oral TabletSCD05e29a60-ebf9-470a-b565-40a6f1f6e1022
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY05e29a60-ebf9-470a-b565-40a6f1f6e1022
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY05e29a60-ebf9-470a-b565-40a6f1f6e1022
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY05e29a60-ebf9-470a-b565-40a6f1f6e1022
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY05e29a60-ebf9-470a-b565-40a6f1f6e1022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-4021-0100378402101100 TABLET in 1 BOTTLE, PLASTIC (0378-4021-01) 100 tablet2000-10-200000-00-00NoNoCurrent