FDA.reportPublic FDA data

voriconazole

Product NDC
65841-830
11-digit product format
658410830
Labeler code
65841
Product ID
65841-830_7666344f-3ba8-4a08-a828-65b846868dc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA206747
Marketing category
ANDA
Marketing start
2016-05-25
Substance
VORICONAZOLE
Active strength
50 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
VORICONAZOLE50 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
65841-830-01voriconazole100 in 1 BOTTLETABLET, FILM COATED10017
65841-830-05voriconazole500 in 1 BOTTLETABLET, FILM COATED50017
65841-830-06voriconazole30 in 1 BOTTLETABLET, FILM COATED3017
65841-830-10voriconazole1000 in 1 BOTTLETABLET, FILM COATED100017
65841-830-16voriconazole90 in 1 BOTTLETABLET, FILM COATED9017
65841-830-30voriconazole10 in 1 BLISTER PACKTABLET, FILM COATED1017
65841-830-77voriconazole10 in 1 CARTONTABLET, FILM COATED1017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-830VORICONAZOLE TABLET [ZYDUS LIFESCIENCES LIMITED]14Current NDC, Legacy NDC, 7 package rows20250430_bda70104-d84b-4d3f-9ca0-5f4f1ca816ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSNbda70104-d84b-4d3f-9ca0-5f4f1ca816ad17
349435voriconazole 50 MG Oral TabletPSNbda70104-d84b-4d3f-9ca0-5f4f1ca816ad17
349434voriconazole 200 MG Oral TabletSCDbda70104-d84b-4d3f-9ca0-5f4f1ca816ad17
349435voriconazole 50 MG Oral TabletSCDbda70104-d84b-4d3f-9ca0-5f4f1ca816ad17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-830-0165841083001100 TABLET, FILM COATED in 1 BOTTLE (65841-830-01) 2016-05-250000-00-00NoNoCurrent
65841-830-0565841083005500 TABLET, FILM COATED in 1 BOTTLE (65841-830-05) 2016-05-250000-00-00NoNoCurrent
65841-830-066584108300630 TABLET, FILM COATED in 1 BOTTLE (65841-830-06) 2016-05-250000-00-00NoNoCurrent
65841-830-10658410830101000 TABLET, FILM COATED in 1 BOTTLE (65841-830-10) 2016-05-250000-00-00NoNoCurrent
65841-830-166584108301690 TABLET, FILM COATED in 1 BOTTLE (65841-830-16) 2016-05-250000-00-00NoNoCurrent
65841-830-306584108303010 in 1 BLISTER PACKHistorical
65841-830-776584108307710 BLISTER PACK in 1 CARTON (65841-830-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-830-30) 10 blister pack2016-05-250000-00-00NoNoCurrent