Fluconazole

Product NDC
70985-014
11-digit product format
709850014
Labeler code
70985
Product ID
70985-014_eb51cf40-8e0c-3478-e053-2995a90ac6e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Drug Ocean LLC
Application
ANDA076957
Marketing category
ANDA
Marketing start
2021-06-26
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
100 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70985-014FLUCONAZOLE TABLET [DRUG OCEAN LLC]14Legacy NDC20241118_c5bfc182-b35f-afc4-e053-2a95a90ae5c3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70985-014-0170985001401100 TABLET in 1 BOTTLE (70985-014-01) 100 tablet2021-06-260000-00-00NoNoCurrent
70985-014-037098500140330 TABLET in 1 BOTTLE (70985-014-03) 30 tablet2021-06-260000-00-00NoNoCurrent