FDA.reportPublic FDA data

voriconazole

Product NDC
72578-063
11-digit product format
725780063
Labeler code
72578
Product ID
72578-063_66fc1497-5ec6-40b6-b77c-9decfe476c9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA206747
Marketing category
ANDA
Marketing start
2019-04-16
Substance
VORICONAZOLE
Active strength
200 mg/1
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORICONAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFU09I87TR
Rxcui349434, 349435

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1f86875f-c0c9-343f-b96c-14093866e7a9Product name920190409
591c07fa-4d24-4cb9-9efc-86997c696aa7Product name120170602

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-063-01voriconazole100 in 1 BOTTLETABLET, FILM COATED10015
72578-063-05voriconazole500 in 1 BOTTLETABLET, FILM COATED50015
72578-063-06voriconazole30 in 1 BOTTLETABLET, FILM COATED3015
72578-063-10voriconazole1000 in 1 BOTTLETABLET, FILM COATED100015
72578-063-16voriconazole90 in 1 BOTTLETABLET, FILM COATED9015
72578-063-30voriconazole10 in 1 BLISTER PACKTABLET, FILM COATED1015
72578-063-77voriconazole10 in 1 CARTONTABLET, FILM COATED1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-063-06EA - Each72578-063bdc1775f-ef44-4965-bd42-20cfbe68552912019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-063VORICONAZOLE TABLET [VIONA PHARMACEUTICALS INC]12Current NDC, Legacy NDC, 7 package rows20250430_75fcbea8-8eeb-4528-b7d9-a059dd25da83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSN75fcbea8-8eeb-4528-b7d9-a059dd25da8315
349435voriconazole 50 MG Oral TabletPSN75fcbea8-8eeb-4528-b7d9-a059dd25da8315
349434voriconazole 200 MG Oral TabletSCD75fcbea8-8eeb-4528-b7d9-a059dd25da8315
349435voriconazole 50 MG Oral TabletSCD75fcbea8-8eeb-4528-b7d9-a059dd25da8315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-063-0172578006301100 TABLET, FILM COATED in 1 BOTTLE (72578-063-01) 2019-04-160000-00-00NoNoCurrent
72578-063-0572578006305500 TABLET, FILM COATED in 1 BOTTLE (72578-063-05) 2019-04-160000-00-00NoNoCurrent
72578-063-067257800630630 TABLET, FILM COATED in 1 BOTTLE (72578-063-06) 2019-04-160000-00-00NoNoCurrent
72578-063-10725780063101000 TABLET, FILM COATED in 1 BOTTLE (72578-063-10) 2019-04-160000-00-00NoNoCurrent
72578-063-167257800631690 TABLET, FILM COATED in 1 BOTTLE (72578-063-16) 2019-04-160000-00-00NoNoCurrent
72578-063-307257800633010 in 1 BLISTER PACKHistorical
72578-063-777257800637710 BLISTER PACK in 1 CARTON (72578-063-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72578-063-30) 10 blister pack2019-04-160000-00-00NoNoCurrent