FDA.reportPublic FDA data

VFEND

Product NDC
0049-3180
11-digit product format
000493180
Labeler code
0049
Product ID
0049-3180_cf9f1b2e-eeb4-48bb-9f1a-c2b8d94dfbea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Roerig
Application
NDA021266
Marketing category
NDA
Marketing start
2003-03-28
Marketing end
2027-04-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VFEND

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORICONAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFU09I87TR
Rxcui349434, 349435, 351209, 352218, 352219, 352220, 465355, 546624

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
0049-3180-302024-01-30C16284748780-11030e365-1802-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VFEND safely and effectively. See full prescribing information for VFEND. VFEND ® (voriconazole) tablets, for oral use VFEND ® (voriconazole) for oral suspension VFEND ® (voriconazole) for injection, for intravenous use Initial U.S. Approval: 2002
0049-3180-302024-01-30C16284748780-11030e365-1802-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VFEND safely and effectively. See full prescribing information for VFEND. VFEND ® (voriconazole) tablets, for oral use VFEND ® (voriconazole) for oral suspension VFEND ® (voriconazole) for injection, for intravenous use Initial U.S. Approval: 2002
0049-3180-302024-01-30C16284748780-11030e365-1802-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VFEND safely and effectively. See full prescribing information for VFEND. VFEND ® (voriconazole) tablets, for oral use VFEND ® (voriconazole) for oral suspension VFEND ® (voriconazole) for injection, for intravenous use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0049-3180-30VFEND30 in 1 BOTTLETABLET, FILM COATED3058

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-3180-30EA - Each0049-3180a773553a-7d8b-4fff-b0ff-333469df296812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VORICONAZOLEACTIVE INGREDIENTJFU09I87TRVFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
VORICONAZOLEACTIVE MOIETYJFU09I87TRVFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLVFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
POVIDONESINACTIVE INGREDIENTFZ989GH94EVFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUVFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
SUCROSEINACTIVE INGREDIENTC151H8M554VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
SULFOBUTYLETHER .BETA.-CYCLODEXTRININACTIVE INGREDIENT2PP9364507VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
TRIACETININACTIVE INGREDIENTXHX3C3X673VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KVFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEVFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-3180VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG]54Current NDC, Legacy NDC, 1 package rows20250323_ce3ef5cf-3087-4d92-9d94-9eb8287228db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352220Vfend 200 MG InjectionPSNce3ef5cf-3087-4d92-9d94-9eb8287228db58
352219Vfend 200 MG Oral TabletPSNce3ef5cf-3087-4d92-9d94-9eb8287228db58
546624Vfend 40 MG in 1 mL Oral SuspensionPSNce3ef5cf-3087-4d92-9d94-9eb8287228db58
352218Vfend 50 MG Oral TabletPSNce3ef5cf-3087-4d92-9d94-9eb8287228db58
351209voriconazole 200 MG InjectionPSNce3ef5cf-3087-4d92-9d94-9eb8287228db58
349434voriconazole 200 MG Oral TabletPSNce3ef5cf-3087-4d92-9d94-9eb8287228db58
465355voriconazole 40 MG in 1 mL Oral SuspensionPSNce3ef5cf-3087-4d92-9d94-9eb8287228db58
349435voriconazole 50 MG Oral TabletPSNce3ef5cf-3087-4d92-9d94-9eb8287228db58
352220voriconazole 200 MG Injection [Vfend]SBDce3ef5cf-3087-4d92-9d94-9eb8287228db58
352219voriconazole 200 MG Oral Tablet [Vfend]SBDce3ef5cf-3087-4d92-9d94-9eb8287228db58
546624voriconazole 40 MG/ML Oral Suspension [Vfend]SBDce3ef5cf-3087-4d92-9d94-9eb8287228db58
352218voriconazole 50 MG Oral Tablet [Vfend]SBDce3ef5cf-3087-4d92-9d94-9eb8287228db58
351209voriconazole 200 MG InjectionSCDce3ef5cf-3087-4d92-9d94-9eb8287228db58
349434voriconazole 200 MG Oral TabletSCDce3ef5cf-3087-4d92-9d94-9eb8287228db58
465355voriconazole 40 MG/ML Oral SuspensionSCDce3ef5cf-3087-4d92-9d94-9eb8287228db58
349435voriconazole 50 MG Oral TabletSCDce3ef5cf-3087-4d92-9d94-9eb8287228db58
352220Vfend 200 MG InjectionSYce3ef5cf-3087-4d92-9d94-9eb8287228db58
352219Vfend 200 MG Oral TabletSYce3ef5cf-3087-4d92-9d94-9eb8287228db58
546624Vfend 200 MG per 5 ML Oral SuspensionSYce3ef5cf-3087-4d92-9d94-9eb8287228db58
546624Vfend 40 MG per 1 ML Oral SuspensionSYce3ef5cf-3087-4d92-9d94-9eb8287228db58
546624Vfend 40 MG/ML Oral SuspensionSYce3ef5cf-3087-4d92-9d94-9eb8287228db58
352218Vfend 50 MG Oral TabletSYce3ef5cf-3087-4d92-9d94-9eb8287228db58
465355voriconazole 200 MG/5 ML Oral SuspensionSYce3ef5cf-3087-4d92-9d94-9eb8287228db58
465355voriconazole 40 MG per 1 ML Oral SuspensionSYce3ef5cf-3087-4d92-9d94-9eb8287228db58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0049-3180-300004931803030 TABLET, FILM COATED in 1 BOTTLE (0049-3180-30) 2003-03-282027-04-30NoNoCurrent