Voriconazole

Product NDC
16714-198
11-digit product format
167140198
Labeler code
16714
Product ID
16714-198_45de5a3f-4e1f-4870-b4aa-3057e4e2ba7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA206837
Marketing category
ANDA
Marketing start
2016-01-22
Marketing end
2027-04-30
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
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
JFU09I87TRVORICONAZOLE137234-62-9VORICONAZOLE

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-198-011671401980130 TABLET, FILM COATED in 1 BOTTLE (16714-198-01) 2016-01-222027-04-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
VoriconazoleNorthStar Rx LLC | Aurobindo Pharma Limited2025-05-02Human Prescription Drug Label6