fluconazole

Product NDC
70934-935
11-digit product format
709340935
Labeler code
70934
Product ID
70934-935_d3a8edf1-8a26-3355-e053-2995a90ae452
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA208963
Marketing category
ANDA
Marketing start
2021-12-16
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-935-072023-01-30C16284748780-1f386c64a-10cf-0266-e053-dadaa90a7c1aFluconazole Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-935-07fluconazole7 in 1 BOTTLE, PLASTICTABLET71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-935FLUCONAZOLE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]1Legacy NDC, 1 package rows20211229_d3a8f0e4-cf55-2df6-e053-2a95a90a221c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNd3a8f0e4-cf55-2df6-e053-2a95a90a221c1
197698fluconazole 100 MG Oral TabletSCDd3a8f0e4-cf55-2df6-e053-2a95a90a221c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-935-07709340935077 TABLET in 1 BOTTLE, PLASTIC (70934-935-07) 7 tablet2021-12-160000-00-00NoNoCurrent