FDA.reportPublic FDA data

Voriconazole

Product NDC
51079-165
11-digit product format
510790165
Labeler code
51079
Product ID
51079-165_3a879fbf-a5ce-949d-e063-6394a90a90d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA090547
Marketing category
ANDA
Marketing start
2011-08-08
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Voriconazole
Listing expiration
2026-12-31

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
51079-165-01Voriconazole1 in 1 BLISTER PACKTABLET, FILM COATED115
51079-165-03Voriconazole30 in 1 CARTONTABLET, FILM COATED3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-165-01EA - Each51079-1656b9eb4b7-9f69-4508-844b-a0086a57ff9c12012-07-24
51079-165-03EA - Each51079-165f5830804-1ea7-4aa5-a5bd-9ffbfe6da62512012-07-24
51079-165-20EA - Each51079-1656fd4d481-45e7-4eaa-a374-91f4af1c877e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VORICONAZOLEACTIVE INGREDIENTJFU09I87TRVORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]6
VORICONAZOLEACTIVE MOIETYJFU09I87TRVORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EVORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-165VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]14Current NDC, Legacy NDC, 2 package rows20250129_3af8cfe6-1c0d-4b57-ae31-05cffa64132e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSN3af8cfe6-1c0d-4b57-ae31-05cffa64132e15
349435voriconazole 50 MG Oral TabletPSN3af8cfe6-1c0d-4b57-ae31-05cffa64132e15
349434voriconazole 200 MG Oral TabletSCD3af8cfe6-1c0d-4b57-ae31-05cffa64132e15
349435voriconazole 50 MG Oral TabletSCD3af8cfe6-1c0d-4b57-ae31-05cffa64132e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-165-01510790165011 in 1 BLISTER PACKHistorical
51079-165-035107901650330 BLISTER PACK in 1 CARTON (51079-165-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-165-01) 30 blister pack2011-08-080000-00-00NoNoCurrent