FDA.reportPublic FDA data

voriconazole

Product NDC
40032-089
11-digit product format
400320089
Labeler code
40032
Product ID
40032-089_a5c6201e-83da-448e-9a57-fd5c8a2d3751
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA207371
Marketing category
ANDA
Marketing start
2016-05-24
Marketing end
0000-00-00
Substance
VORICONAZOLE
Active strength
200 mg/1
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
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
1f86875f-c0c9-343f-b96c-14093866e7a9Product name920190409
591c07fa-4d24-4cb9-9efc-86997c696aa7Product name120170602

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40032-089-032023-01-30C16284748780-1f386c64a-0e48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VORICONAZOLE TABLETS safely and effectively. See full prescribing information for VORICONAZOLE TABLETS. VORICONAZOLE tablets for oral use Initial U.S. Approval: 2002
40032-089-052023-01-30C16284748780-1f386c64a-0e48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VORICONAZOLE TABLETS safely and effectively. See full prescribing information for VORICONAZOLE TABLETS. VORICONAZOLE tablets for oral use Initial U.S. Approval: 2002
40032-089-312023-01-30C16284748780-1f386c64a-0e48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VORICONAZOLE TABLETS safely and effectively. See full prescribing information for VORICONAZOLE TABLETS. VORICONAZOLE tablets for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-089-03voriconazole30 in 1 BOTTLETABLET, FILM COATED303
40032-089-05voriconazole500 in 1 BOTTLETABLET, FILM COATED5003
40032-089-30voriconazole10 in 1 BLISTER PACKTABLET, FILM COATED103
40032-089-31voriconazole3 in 1 CARTONTABLET, FILM COATED33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-089VORICONAZOLE TABLET, FILM COATED [NOVEL LABORATORIES, INC.]3Legacy NDC, 4 package rows20191221_c6b444dd-7ad9-4fb2-a444-2f3ece8a8353.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSNc6b444dd-7ad9-4fb2-a444-2f3ece8a83533
349435voriconazole 50 MG Oral TabletPSNc6b444dd-7ad9-4fb2-a444-2f3ece8a83533
349434voriconazole 200 MG Oral TabletSCDc6b444dd-7ad9-4fb2-a444-2f3ece8a83533
349435voriconazole 50 MG Oral TabletSCDc6b444dd-7ad9-4fb2-a444-2f3ece8a83533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-089-034003200890330 TABLET, FILM COATED in 1 BOTTLE (40032-089-03) 2016-05-240000-00-00NoNoCurrent
40032-089-0540032008905500 TABLET, FILM COATED in 1 BOTTLE (40032-089-05) 2016-05-240000-00-00NoNoCurrent
40032-089-304003200893010 in 1 BLISTER PACKHistorical
40032-089-31400320089313 BLISTER PACK in 1 CARTON (40032-089-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK (40032-089-30) 3 blister pack2016-05-240000-00-00NoNoCurrent