voriconazole

Product NDC
0904-6596
11-digit product format
009046596
Labeler code
0904
Product ID
0904-6596_af2892fb-c3b7-45ea-93b8-ecf45fe057fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
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
Rxcui349435

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
0904-6596-04voriconazole30 in 1 CARTONTABLET, FILM COATED309
0904-6596-04voriconazole1 in 1 BLISTER PACKTABLET, FILM COATED19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6596-04EA - Each0904-659629ffe75a-f006-4695-8b09-00739d11ba3412017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6596VORICONAZOLE TABLET [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20250402_49dcf3ae-6d6b-46fe-a88e-ec65f2de332e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349435voriconazole 50 MG Oral TabletPSN49dcf3ae-6d6b-46fe-a88e-ec65f2de332e9
349435voriconazole 50 MG Oral TabletSCD49dcf3ae-6d6b-46fe-a88e-ec65f2de332e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6596-040090465960430 BLISTER PACK in 1 CARTON (0904-6596-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2016-05-250000-00-00NoNoCurrent