FDA.reportPublic FDA data

Fluconazole

Product NDC
12634-780
11-digit product format
126340780
Labeler code
12634
Product ID
12634-780_277154a2-2784-3775-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
150 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
2019-12-31
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
12634-780-012020-01-31C16284748780-19d75b9d0-d6d5-f424-e053-dadaa90a57ceFluconazole Tablets USP Rx only
12634-780-602020-01-31C16284748780-19d75b9d0-d6d5-f424-e053-dadaa90a57ceFluconazole Tablets USP Rx only
12634-780-762020-01-31C16284748780-19d75b9d0-d6d5-f424-e053-dadaa90a57ceFluconazole Tablets USP Rx only
12634-780-912020-01-31C16284748780-19d75b9d0-d6d5-f424-e053-dadaa90a57ceFluconazole Tablets USP Rx only
12634-780-922020-01-31C16284748780-19d75b9d0-d6d5-f424-e053-dadaa90a57ceFluconazole Tablets USP Rx only
12634-780-932020-01-31C16284748780-19d75b9d0-d6d5-f424-e053-dadaa90a57ceFluconazole Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-780-01Fluconazole100 in 1 BOTTLETABLET1001
12634-780-60Fluconazole60 in 1 BOTTLETABLET601
12634-780-76Fluconazole26 in 1 BOTTLETABLET261
12634-780-91Fluconazole1 in 1 BLISTER PACKTABLET11
12634-780-92Fluconazole2 in 1 BOTTLETABLET21
12634-780-93Fluconazole3 in 1 BOTTLETABLET31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-780FLUCONAZOLE TABLET [APOTHECA INC.]1Legacy NDC, 6 package rows20151222_277154a2-2783-3775-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN277154a2-2783-3775-e054-00144ff88e881
197699fluconazole 150 MG Oral TabletSCD277154a2-2783-3775-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-780-0112634078001100 in 1 BOTTLEHistorical
12634-780-601263407806060 in 1 BOTTLEHistorical
12634-780-761263407807626 in 1 BOTTLEHistorical
12634-780-91126340780911 in 1 BLISTER PACKHistorical
12634-780-92126340780922 in 1 BOTTLEHistorical
12634-780-93126340780933 in 1 BOTTLEHistorical