FDA.reportPublic FDA data

Fluconazole

Product NDC
82804-030
11-digit product format
828040030
Labeler code
82804
Product ID
82804-030_fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
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
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
82804-030-30Fluconazole30 in 1 BOTTLETABLET301
82804-030-60Fluconazole60 in 1 BOTTLETABLET601
82804-030-90Fluconazole90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-030-30EA - Each82804-030c8059eb4-75df-4690-af08-5a76a50dd9fd12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-030FLUCONAZOLE TABLET [PROFICIENT RX LP]1Current NDC, 3 package rows20231024_fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSNfc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f1
197700fluconazole 200 MG Oral TabletSCDfc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-030-308280400303030 TABLET in 1 BOTTLE (82804-030-30) 30 tablet2023-10-20NoNoCurrent
82804-030-608280400306060 TABLET in 1 BOTTLE (82804-030-60) 60 tablet2023-10-20NoNoCurrent
82804-030-908280400309090 TABLET in 1 BOTTLE (82804-030-90) 90 tablet2023-10-20NoNoCurrent