FLUCONAZOLE

Product NDC
62135-132
11-digit product format
621350132
Labeler code
62135
Product ID
62135-132_25892746-5194-5955-e063-6294a90a3b7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUCONAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA076665
Marketing category
ANDA
Marketing start
2004-07-29
Substance
FLUCONAZOLE
Active strength
150 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
FLUCONAZOLE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698, 197699, 197700, 197701

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
62135-132-77FLUCONAZOLE1 in 1 BOTTLETABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-132-77EA - Each62135-132afa4f22b-8aba-4405-bab2-12c029011d9e12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-132FLUCONAZOLE TABLET [CHARTWELL RX, LLC]4Current NDC, Legacy NDC, 1 package rows20241030_f86ea347-78f5-43b8-9574-a52569a4237b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNf86ea347-78f5-43b8-9574-a52569a4237b4
197699fluconazole 150 MG Oral TabletPSNf86ea347-78f5-43b8-9574-a52569a4237b4
197700fluconazole 200 MG Oral TabletPSNf86ea347-78f5-43b8-9574-a52569a4237b4
197701fluconazole 50 MG Oral TabletPSNf86ea347-78f5-43b8-9574-a52569a4237b4
197698fluconazole 100 MG Oral TabletSCDf86ea347-78f5-43b8-9574-a52569a4237b4
197699fluconazole 150 MG Oral TabletSCDf86ea347-78f5-43b8-9574-a52569a4237b4
197700fluconazole 200 MG Oral TabletSCDf86ea347-78f5-43b8-9574-a52569a4237b4
197701fluconazole 50 MG Oral TabletSCDf86ea347-78f5-43b8-9574-a52569a4237b4
197699fluconazole 150 MG Oral TabletPSN3208dc64-6117-4b2d-9008-76a819cef7d71
197699fluconazole 150 MG Oral TabletSCD3208dc64-6117-4b2d-9008-76a819cef7d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-132-77621350132771 TABLET in 1 BOTTLE (62135-132-77) 1 tablet2022-12-080000-00-00NoNoCurrent