FDA.reportPublic FDA data

Doxazosin

Product NDC
68071-4892
11-digit product format
680714892
Labeler code
68071
Product ID
68071-4892_297e74b0-5b39-7420-e063-6294a90aa73d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208719
Marketing category
ANDA
Marketing start
2017-08-31
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
Doxazosin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86P6PQK0MU
Rxcui197627

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4892-92024-06-14C16284748780-1ba0f9c33-44d6-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DOXAZOCIN TABLETS safely and effectively. See full prescribing information for DOXAZOCIN TABLETS. DOXAZOSIN TABLETS, for oral use Initial U.S. Approval: 1990
68071-4892-92023-01-30C16284748780-1ba0f9c33-44d6-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DOXAZOCIN TABLETS safely and effectively. See full prescribing information for DOXAZOCIN TABLETS. DOXAZOSIN TABLETS, for oral use Initial U.S. Approval: 1990
68071-4892-92021-02-17C16284748780-1ba0f9c33-44d6-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DOXAZOCIN TABLETS safely and effectively. See full prescribing information for DOXAZOCIN TABLETS. DOXAZOSIN TABLETS, for oral use Initial U.S. Approval: 1990
68071-4892-92021-01-29C16284748780-1ba0f9c33-44d6-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DOXAZOCIN TABLETS safely and effectively. See full prescribing information for DOXAZOCIN TABLETS. DOXAZOSIN TABLETS, for oral use Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4892-3Doxazosin30 in 1 BOTTLETABLET305
68071-4892-9Doxazosin90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4892DOXAZOSIN TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 2 package rows20241220_88efdfb0-710f-768a-e053-2995a90aede4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197627doxazosin mesylate 4 MG Oral TabletPSN88efdfb0-710f-768a-e053-2995a90aede45
197627doxazosin 4 MG Oral TabletSCD88efdfb0-710f-768a-e053-2995a90aede45
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY88efdfb0-710f-768a-e053-2995a90aede45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4892-36807148920330 TABLET in 1 BOTTLE (68071-4892-3) 30 tablet2024-12-17NoNoHistorical
68071-4892-96807148920990 TABLET in 1 BOTTLE (68071-4892-9) 90 tablet2019-05-150000-00-00NoNoCurrent