FDA.reportPublic FDA data

Fluconazole

Product NDC
50268-339
11-digit product format
502680339
Labeler code
50268
Product ID
50268-339_47bacb91-b009-2ce7-e063-6394a90a0eac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA077731
Marketing category
ANDA
Marketing start
2016-09-09
Substance
FLUCONAZOLE
Active strength
200 mg/1
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
Fluconazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698, 197700

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
50268-339-11Fluconazole1 in 1 BLISTER PACKTABLET110
50268-339-15Fluconazole50 in 1 BOXTABLET5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-339-11EA - Each50268-3394d2acfc3-b007-4581-8ddc-2aad0607edc312016-11-08
50268-339-15EA - Each50268-339464cd4bf-2c5a-40dc-b60a-3307cdd23ec212016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-339FLUCONAZOLE TABLET [AVPAK]9Current NDC, Legacy NDC, 2 package rows20240110_551a5c8f-57eb-2643-12c6-7c700584b49f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN551a5c8f-57eb-2643-12c6-7c700584b49f10
197700fluconazole 200 MG Oral TabletPSN551a5c8f-57eb-2643-12c6-7c700584b49f10
197698fluconazole 100 MG Oral TabletSCD551a5c8f-57eb-2643-12c6-7c700584b49f10
197700fluconazole 200 MG Oral TabletSCD551a5c8f-57eb-2643-12c6-7c700584b49f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-339-11502680339111 in 1 BLISTER PACKHistorical
50268-339-155026803391550 BLISTER PACK in 1 BOX (50268-339-15) / 1 TABLET in 1 BLISTER PACK (50268-339-11) 50 blister pack2016-09-090000-00-00NoNoCurrent