Voriconazole

Product NDC
48433-147
11-digit product format
484330147
Labeler code
48433
Product ID
48433-147_4ee324a6-c4ce-a10c-e063-6294a90a5060
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safecor Health LLC
Application
ANDA090547
Marketing category
ANDA
Marketing start
2026-04-06
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
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
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
48433-147-01Voriconazole1 in 1 BLISTER PACKTABLET, FILM COATED12
48433-147-03Voriconazole30 in 1 CARTONTABLET, FILM COATED302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSN23f25c6b-f075-42dc-ae05-63b5bf4109293
349435voriconazole 50 MG Oral TabletPSN23f25c6b-f075-42dc-ae05-63b5bf4109293
349434voriconazole 200 MG Oral TabletSCD23f25c6b-f075-42dc-ae05-63b5bf4109293
349435voriconazole 50 MG Oral TabletSCD23f25c6b-f075-42dc-ae05-63b5bf4109293

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-147-01484330147011 in 1 BLISTER PACKHistorical
48433-147-034843301470330 BLISTER PACK in 1 CARTON (48433-147-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-147-01) 30 blister pack2026-04-06NoNoCurrent