fluconazole

Product NDC
71205-283
11-digit product format
712050283
Labeler code
71205
Product ID
71205-283_1410a251-cc08-49a0-b4aa-dfd217bca85b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208963
Marketing category
ANDA
Marketing start
2017-04-06
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
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
FLUCONAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197700

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
71205-283-30fluconazole30 in 1 BOTTLETABLET302
71205-283-60fluconazole60 in 1 BOTTLETABLET602
71205-283-90fluconazole90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-283-30EA - Each71205-2831c7808e6-80fe-4d6a-8e1a-6cf24434413812019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-283FLUCONAZOLE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20200313_f232600e-70ce-4001-b9da-31442f0920b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSNf232600e-70ce-4001-b9da-31442f0920b92
197700fluconazole 200 MG Oral TabletSCDf232600e-70ce-4001-b9da-31442f0920b92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-283-307120502833030 TABLET in 1 BOTTLE (71205-283-30) 30 tablet2019-06-010000-00-00NoNoCurrent
71205-283-607120502836060 TABLET in 1 BOTTLE (71205-283-60) 60 tablet2019-06-010000-00-00NoNoCurrent
71205-283-907120502839090 TABLET in 1 BOTTLE (71205-283-90) 90 tablet2019-06-010000-00-00NoNoCurrent