FDA.reportPublic FDA data

Doxazosin

Product NDC
42291-260
11-digit product format
422910260
Labeler code
42291
Product ID
42291-260_4dc7e86f-ca0f-f5d0-e063-6394a90a4eed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA075580
Marketing category
ANDA
Marketing start
2015-04-09
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86P6PQK0MU
Rxcui197626, 197627, 197628

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
42291-260-01Doxazosin100 in 1 BOTTLETABLET10010
42291-260-10Doxazosin1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-260-01EA - Each42291-260a71a5e92-796c-417a-b197-bf8eace014a312015-05-05
42291-260-10EA - Each42291-26021548681-b60b-485b-9515-bb920fc2b60e12018-07-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUDOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
DOXAZOSINACTIVE MOIETYNW1291F1W8DOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXAZOSIN (DOXAZOSIN) TABLET [AVKARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-260DOXAZOSIN TABLET [AVKARE]8Current NDC, Legacy NDC, 2 package rows20240110_e3d381c1-3b2f-af70-f4e6-08d6202eed25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197626doxazosin mesylate 2 MG Oral TabletPSNe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197627doxazosin mesylate 4 MG Oral TabletPSNe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197628doxazosin mesylate 8 MG Oral TabletPSNe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197626doxazosin 2 MG Oral TabletSCDe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197627doxazosin 4 MG Oral TabletSCDe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197628doxazosin 8 MG Oral TabletSCDe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYe3d381c1-3b2f-af70-f4e6-08d6202eed2510
197626doxazosin mesylate 2 MG Oral TabletPSNf1dc70f6-4329-46da-8990-7bd6eec9d37d2
197628doxazosin mesylate 8 MG Oral TabletPSNf1dc70f6-4329-46da-8990-7bd6eec9d37d2
197626doxazosin 2 MG Oral TabletSCDf1dc70f6-4329-46da-8990-7bd6eec9d37d2
197628doxazosin 8 MG Oral TabletSCDf1dc70f6-4329-46da-8990-7bd6eec9d37d2
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYf1dc70f6-4329-46da-8990-7bd6eec9d37d2
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYf1dc70f6-4329-46da-8990-7bd6eec9d37d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-260-0142291026001100 TABLET in 1 BOTTLE (42291-260-01) 100 tablet2015-04-090000-00-00NoNoCurrent
42291-260-10422910260101000 TABLET in 1 BOTTLE (42291-260-10) 1000 tablet2018-05-310000-00-00NoNoCurrent