fluconazole

Product NDC
68071-2601
11-digit product format
680712601
Labeler code
68071
Product ID
68071-2601_d35c476f-44c5-1d5c-e053-2a95a90ae3f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208963
Marketing category
ANDA
Marketing start
2017-04-06
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 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2601-7fluconazole7 in 1 BOTTLETABLET72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2601FLUCONAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20230715_d35c476f-44c4-1d5c-e053-2a95a90ae3f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNd35c476f-44c4-1d5c-e053-2a95a90ae3f92
197698fluconazole 100 MG Oral TabletSCDd35c476f-44c4-1d5c-e053-2a95a90ae3f92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2601-7680712601077 TABLET in 1 BOTTLE (68071-2601-7) 7 tablet2021-12-170000-00-00NoNoCurrent