FDA.reportPublic FDA data

Itraconazole Oral

Product NDC
69339-159
11-digit product format
693390159
Labeler code
69339
Product ID
69339-159_2af07b39-fe93-4961-90cb-ed9c5e2f424d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Itraconazole
Dosage form
SOLUTION
Route
ORAL
Labeler
Natco Pharma USA LLC
Application
ANDA212239
Marketing category
ANDA
Marketing start
2022-04-25
Substance
ITRACONAZOLE
Active strength
10 mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein 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
Itraconazole Oral
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ITRACONAZOLE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii304NUG5GF4
Rxcui348506

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d9fdd44-2f2e-2968-36a7-2e5aa5ad971eProduct name420210511
177ecfe5-1d67-dab4-615e-cac2b457a3c1Product name820191002
9d180e3e-4d31-448b-8857-92c67ed2461aProduct name120190410
7ac2304e-2df8-d230-3b61-1cd07aab1554Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69339-159-01Itraconazole Oral10 mL in 1 CUP, UNIT-DOSESOLUTION102
69339-159-17Itraconazole Oral40 in 1 BOX, UNIT-DOSESOLUTION402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-159-01ML - Milliliter69339-1596c2811ce-c431-4a7f-a075-b13765858a8e12022-05-04
69339-159-17ML - Milliliter69339-159ddd59faa-e4cb-43f8-b1d4-19964974f5a012022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-159ITRACONAZOLE ORAL (ITRACONAZOLE) SOLUTION [NATCO PHARMA USA LLC]2Current NDC, Legacy NDC, 2 package rows20230902_da63870d-b426-4e49-9591-5bb51f962e66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348506itraconazole 10 MG in 1 mL Oral SolutionPSNda63870d-b426-4e49-9591-5bb51f962e662
348506itraconazole 10 MG/ML Oral SolutionSCDda63870d-b426-4e49-9591-5bb51f962e662
348506ICNZ 10 MG/ML Oral SolutionSYda63870d-b426-4e49-9591-5bb51f962e662
348506itraconazole 10 MG per 1 ML Oral SolutionSYda63870d-b426-4e49-9591-5bb51f962e662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69339-159-016933901590110 mL in 1 CUP, UNIT-DOSE10 mlHistorical
69339-159-176933901591740 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-159-17) / 10 mL in 1 CUP, UNIT-DOSE (69339-159-01) 2022-04-250000-00-00NoNoCurrent