FDA.reportPublic FDA data

Fluconazole

Product NDC
0143-9668
11-digit product format
001439668
Labeler code
0143
Product ID
0143-9668_a90257a3-d842-4990-81a5-614293e23119
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078698
Marketing category
ANDA
Marketing start
2012-01-30
Substance
FLUCONAZOLE
Active strength
2 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
Fluconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui1721314, 1721315

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9668-01Fluconazole200 mL in 1 CONTAINERINJECTION20019
0143-9668-10Fluconazole10 in 1 CARTONINJECTION1019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9668FLUCONAZOLE INJECTION [HIKMA PHARMACEUTICALS USA INC.]19Current NDC, Legacy NDC, 2 package rows20240629_d3ca59bd-ae00-48ab-89aa-87c7f56e9989.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721315fluconazole 200 MG in 100 ML InjectionPSNd3ca59bd-ae00-48ab-89aa-87c7f56e998919
1721314fluconazole 400 MG in 200 ML InjectionPSNd3ca59bd-ae00-48ab-89aa-87c7f56e998919
1721315100 ML fluconazole 2 MG/ML InjectionSCDd3ca59bd-ae00-48ab-89aa-87c7f56e998919
1721314200 ML fluconazole 2 MG/ML InjectionSCDd3ca59bd-ae00-48ab-89aa-87c7f56e998919
1721315fluconazole 200 MG per 100 ML InjectionSYd3ca59bd-ae00-48ab-89aa-87c7f56e998919
1721314fluconazole 400 MG per 200 ML InjectionSYd3ca59bd-ae00-48ab-89aa-87c7f56e998919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9668-0100143966801200 mL in 1 CONTAINER200 mlHistorical
0143-9668-06001439668066 CONTAINER in 1 CARTON (0143-9668-06) > 200 mL in 1 CONTAINER (0143-9668-01) 6 container2012-01-300000-00-00NoNoCurrent
0143-9668-100014396681010 CONTAINER in 1 CARTON (0143-9668-10) / 200 mL in 1 CONTAINER (0143-9668-01) 10 container2012-01-30NoNoCurrent