FDA.reportPublic FDA data

FLUCONAZOLE

Product NDC
61919-419
11-digit product format
619190419
Labeler code
61919
Product ID
61919-419_9c9424d4-423d-110f-e053-2995a90ac6c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUCONAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA076077
Marketing category
ANDA
Marketing start
2014-01-01
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
2021-12-31
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
61919-419-102023-01-30C16284748780-1f386c64a-1f92-0266-e053-dadaa90a7c1aFLUCONAZOLE
61919-419-302023-01-30C16284748780-1f386c64a-1f92-0266-e053-dadaa90a7c1aFLUCONAZOLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-419-10FLUCONAZOLE10 in 1 BOTTLETABLET103
61919-419-30FLUCONAZOLE30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-419-10EA - Each61919-41978b6eb45-5354-47c1-9496-d193e1a483f512015-02-02
61919-419-30EA - Each61919-419f4bb1a58-5628-4d6b-9acd-ead3b66f493012015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [DIRECT RX]1
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [DIRECT RX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUCONAZOLE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUCONAZOLE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUCONAZOLE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUCONAZOLE TABLET [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFLUCONAZOLE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-419FLUCONAZOLE TABLET [DIRECT RX]3Legacy NDC, 2 package rows20200121_9164784a-5f7a-4e0d-abb2-5afcf7ef415b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN9164784a-5f7a-4e0d-abb2-5afcf7ef415b3
197698fluconazole 100 MG Oral TabletSCD9164784a-5f7a-4e0d-abb2-5afcf7ef415b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-419-106191904191010 TABLET in 1 BOTTLE (61919-419-10) 10 tablet2015-01-010000-00-00NoNoCurrent
61919-419-306191904193030 TABLET in 1 BOTTLE (61919-419-30) 30 tablet2015-01-010000-00-00NoNoCurrent