Voriconazole

Product NDC
72843-441
11-digit product format
728430441
Labeler code
72843
Product ID
72843-441_37fd1318-4e96-c496-e063-6394a90a90e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
UBI Pharma Inc.
Application
ANDA211264
Marketing category
ANDA
Marketing start
2020-08-31
Substance
VORICONAZOLE
Active strength
10 mg/mL
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Voriconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORICONAZOLE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFU09I87TR
Rxcui351209

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
72843-441-01Voriconazole20 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72843-441VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [UBI PHARMA INC.]8Current NDC, 1 package rows20230315_9a81e485-7f26-45b6-bfd7-6114afb7def9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351209voriconazole 200 MG InjectionPSN9a81e485-7f26-45b6-bfd7-6114afb7def99
351209voriconazole 200 MG InjectionSCD9a81e485-7f26-45b6-bfd7-6114afb7def99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72843-441-017284304410120 mL in 1 VIAL, SINGLE-USE (72843-441-01) 20 ml2020-08-31NoNoHistorical