Fluconazole

Product NDC
51407-427
11-digit product format
514070427
Labeler code
51407
Product ID
51407-427_4a80ede2-17c6-ce12-e063-6294a90a38cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA078423
Marketing category
ANDA
Marketing start
2011-03-07
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, 197699, 197700, 197701

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
51407-427-01Fluconazole100 in 1 BOTTLETABLET10012
51407-427-30Fluconazole30 in 1 BOTTLETABLET3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-427-01EA - Each51407-427c9295835-3ed2-4145-af6a-6c41ceb5409f12021-08-05
51407-427-30EA - Each51407-427ce851840-fa6d-4db9-b725-43579ca1cca212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-427FLUCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]10Current NDC, Legacy NDC, 2 package rows20241213_c2c7242d-d172-4733-e053-2995a90acb2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNc2c7242d-d172-4733-e053-2995a90acb2e12
197699fluconazole 150 MG Oral TabletPSNc2c7242d-d172-4733-e053-2995a90acb2e12
197700fluconazole 200 MG Oral TabletPSNc2c7242d-d172-4733-e053-2995a90acb2e12
197701fluconazole 50 MG Oral TabletPSNc2c7242d-d172-4733-e053-2995a90acb2e12
197698fluconazole 100 MG Oral TabletSCDc2c7242d-d172-4733-e053-2995a90acb2e12
197699fluconazole 150 MG Oral TabletSCDc2c7242d-d172-4733-e053-2995a90acb2e12
197700fluconazole 200 MG Oral TabletSCDc2c7242d-d172-4733-e053-2995a90acb2e12
197701fluconazole 50 MG Oral TabletSCDc2c7242d-d172-4733-e053-2995a90acb2e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-427-0151407042701100 TABLET in 1 BOTTLE (51407-427-01) 100 tablet2021-02-020000-00-00NoNoCurrent
51407-427-305140704273030 TABLET in 1 BOTTLE (51407-427-30) 30 tablet2021-02-020000-00-00NoNoCurrent