FDA.reportPublic FDA data

voriconazole

Product NDC
72673-111
11-digit product format
726730111
Labeler code
72673
Product ID
72673-111_32669bf5-b300-fb86-e063-6394a90a02a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Zhejiang Poly Pharm Co., Ltd.
Application
ANDA216805
Marketing category
ANDA
Marketing start
2025-04-11
Substance
VORICONAZOLE
Active strength
40 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
VORICONAZOLE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFU09I87TR
Rxcui465355

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1f86875f-c0c9-343f-b96c-14093866e7a9Product name920190409
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
591c07fa-4d24-4cb9-9efc-86997c696aa7Product name120170602
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72673-111-30voriconazole75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION752
72673-111-30voriconazole1 in 1 CARTONPOWDER, FOR SUSPENSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72673-111VORICONAZOLE POWDER, FOR SUSPENSION [ZHEJIANG POLY PHARM CO., LTD.]2Current NDC, 2 package rows20250411_3266cf9b-e648-1ff2-e063-6394a90a0487.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
465355voriconazole 40 MG in 1 mL Oral SuspensionPSN3266cf9b-e648-1ff2-e063-6394a90a04872
465355voriconazole 40 MG/ML Oral SuspensionSCD3266cf9b-e648-1ff2-e063-6394a90a04872
465355voriconazole 200 MG/5 ML Oral SuspensionSY3266cf9b-e648-1ff2-e063-6394a90a04872
465355voriconazole 40 MG per 1 ML Oral SuspensionSY3266cf9b-e648-1ff2-e063-6394a90a04872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72673-111-30726730111301 BOTTLE in 1 CARTON (72673-111-30) / 75 mL in 1 BOTTLE1 bottle2025-04-11NoNoHistorical