FDA.reportPublic FDA data

Fluconazole

Product NDC
70436-227
11-digit product format
704360227
Labeler code
70436
Product ID
70436-227_2c3342fa-abe7-d6b0-e063-6394a90ad1c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Slate Run Pharmaceuticals
Application
ANDA215738
Marketing category
ANDA
Marketing start
2024-01-01
Substance
FLUCONAZOLE
Active strength
40 mg/mL
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
FLUCONAZOLE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui310353

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-227-48Fluconazole35 mL in 1 BOTTLEPOWDER, FOR SUSPENSION352
70436-227-48Fluconazole1 in 1 CARTONPOWDER, FOR SUSPENSION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-227-48ML - Milliliter70436-227ed21642e-179f-4839-92a6-be78142604ca12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-227FLUCONAZOLE POWDER, FOR SUSPENSION [SLATE RUN PHARMACEUTICALS]2Current NDC, 2 package rows20250122_13804efd-7cb3-431f-a6a7-bd6d1da5889e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310353fluconazole 40 MG in 1 mL Oral SuspensionPSN13804efd-7cb3-431f-a6a7-bd6d1da5889e2
310353fluconazole 40 MG/ML Oral SuspensionSCD13804efd-7cb3-431f-a6a7-bd6d1da5889e2
310353fluconazole 1400 MG per 35 ML Oral SuspensionSY13804efd-7cb3-431f-a6a7-bd6d1da5889e2
310353fluconazole 200 MG per 5 ML Oral SuspensionSY13804efd-7cb3-431f-a6a7-bd6d1da5889e2
310353fluconazole 40 MG per 1 ML Oral SuspensionSY13804efd-7cb3-431f-a6a7-bd6d1da5889e2
310353fluconazole 40 MG per ML Powder for Oral SuspensionSY13804efd-7cb3-431f-a6a7-bd6d1da5889e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70436-227-48704360227481 BOTTLE in 1 CARTON (70436-227-48) / 35 mL in 1 BOTTLE1 bottle2024-01-01NoNoCurrent