FDA.reportPublic FDA data

Fluconazole

Product NDC
16714-696
11-digit product format
167140696
Labeler code
16714
Product ID
16714-696_95e12350-efed-4dad-8ec3-6aa48fdc1512
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA079150
Marketing category
ANDA
Marketing start
2009-09-18
Substance
FLUCONAZOLE
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
Fluconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui310352, 310353

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-696-01Fluconazole1 in 1 CARTONPOWDER, FOR SUSPENSION120
16714-696-01Fluconazole35 mL in 1 BOTTLEPOWDER, FOR SUSPENSION3520

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-696-01ML - Milliliter16714-6964acb504d-dd84-422e-a5d7-dc5a40813ff812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]6
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]6
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFLUCONAZOLE POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUCONAZOLE POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFLUCONAZOLE POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]6
SUCROSEINACTIVE INGREDIENTC151H8M554FLUCONAZOLE POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUCONAZOLE POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]6
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KFLUCONAZOLE POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]6
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEFLUCONAZOLE POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-696FLUCONAZOLE POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]20Current NDC, Legacy NDC, 2 package rows20240905_afde17e7-b95b-4cd5-97eb-e361724014bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310352fluconazole 10 MG in 1 mL Oral SuspensionPSNafde17e7-b95b-4cd5-97eb-e361724014bd20
310353fluconazole 40 MG in 1 mL Oral SuspensionPSNafde17e7-b95b-4cd5-97eb-e361724014bd20
310352fluconazole 10 MG/ML Oral SuspensionSCDafde17e7-b95b-4cd5-97eb-e361724014bd20
310353fluconazole 40 MG/ML Oral SuspensionSCDafde17e7-b95b-4cd5-97eb-e361724014bd20
310352fluconazole 10 MG per 1 ML Oral SuspensionSYafde17e7-b95b-4cd5-97eb-e361724014bd20
310352fluconazole 10 MG per ML Powder for Oral SuspensionSYafde17e7-b95b-4cd5-97eb-e361724014bd20
310353fluconazole 1400 MG per 35 ML Oral SuspensionSYafde17e7-b95b-4cd5-97eb-e361724014bd20
310353fluconazole 200 MG per 5 ML Oral SuspensionSYafde17e7-b95b-4cd5-97eb-e361724014bd20
310352fluconazole 350 MG per 35 ML Powder for Oral SuspensionSYafde17e7-b95b-4cd5-97eb-e361724014bd20
310353fluconazole 40 MG per 1 ML Oral SuspensionSYafde17e7-b95b-4cd5-97eb-e361724014bd20
310353fluconazole 40 MG per ML Powder for Oral SuspensionSYafde17e7-b95b-4cd5-97eb-e361724014bd20
310352fluconazole 50 MG per 5 ML Powder for Oral SuspensionSYafde17e7-b95b-4cd5-97eb-e361724014bd20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-696-01167140696011 BOTTLE in 1 CARTON (16714-696-01) / 35 mL in 1 BOTTLE1 bottle2009-09-180000-00-00NoNoCurrent