FDA.reportPublic FDA data

Voriconazole

Product NDC
59762-0934
11-digit product format
597620934
Labeler code
59762
Product ID
59762-0934_b21944f6-8755-4783-8906-9ba116f34d82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Greenstone LLC
Application
NDA021266
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-12-15
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59762-0934-12024-01-30C16284748780-11030e365-2ff4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use voriconazole safely and effectively. See full prescribing information for voriconazole. Voriconazole tablets, for oral use Voriconazole for oral suspension Initial U.S. Approval: 2002
59762-0934-12024-01-30C16284748780-11030e365-2ff4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use voriconazole safely and effectively. See full prescribing information for voriconazole. Voriconazole for oral suspension Initial U.S. Approval: 2002
59762-0934-12024-01-30C16284748780-11030e365-2ff4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use voriconazole safely and effectively. See full prescribing information for voriconazole. Voriconazole for oral suspension Initial U.S. Approval: 2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0934-1EA - Each59762-09343cc62ec5-aa35-420d-a19a-2854593fbded12017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VORICONAZOLEACTIVE INGREDIENTJFU09I87TRVORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]12
VORICONAZOLEACTIVE MOIETYJFU09I87TRVORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]12
POVIDONESINACTIVE INGREDIENTFZ989GH94EVORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]12
TRIACETININACTIVE INGREDIENTXHX3C3X673VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0934VORICONAZOLE POWDER, FOR SUSPENSION VORICONAZOLE TABLET, FILM COATED [GREENSTONE LLC]57Legacy NDC20250331_b8de04a0-238d-4e0b-b0d9-7f7878b149d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0934-15976209340130 TABLET, FILM COATED in 1 BOTTLE (59762-0934-1) 2010-07-080000-00-00NoNoCurrent