VORICONAZOLE

Product NDC
14335-730
11-digit product format
143350730
Labeler code
14335
Product ID
14335-730_4ce54074-b0ac-3c98-e063-6394a90a9131
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VORICONAZOLE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hainan Poly Pharm. Co., Ltd.
Application
ANDA220043
Marketing category
ANDA
Marketing start
2025-11-20
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
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
VORICONAZOLE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFU09I87TR
Rxcui2727399

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
14335-730-10VORICONAZOLE20 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION202
14335-730-10VORICONAZOLE1 in 1 CARTONINJECTION, SOLUTION12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2727399voriconazole 200 MG in 20 ML InjectionPSN393a81ba-7d51-450e-8d20-23287767c0022
272739920 ML voriconazole 10 MG/ML InjectionSCD393a81ba-7d51-450e-8d20-23287767c0022
2727399voriconazole 200 MG per 20 ML InjectionSY393a81ba-7d51-450e-8d20-23287767c0022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
14335-730-10143350730101 VIAL, SINGLE-USE in 1 CARTON (14335-730-10) / 20 mL in 1 VIAL, SINGLE-USE2025-11-20NoNoHistorical