FDA.reportPublic FDA data

Itraconazole

Product NDC
67877-454
11-digit product format
678770454
Labeler code
67877
Product ID
67877-454_17ebcbb4-d52b-44b8-a4ef-42ddae5034db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Itraconazole
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA208591
Marketing category
ANDA
Marketing start
2017-06-12
Substance
ITRACONAZOLE
Active strength
100 mg/1
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ITRACONAZOLE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii304NUG5GF4
Rxcui311204

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
67877-454-05Itraconazole500 in 1 BOTTLECAPSULE, COATED PELLETS50021
67877-454-30Itraconazole30 in 1 BOTTLECAPSULE, COATED PELLETS3021
67877-454-33Itraconazole10 in 1 BLISTER PACKCAPSULE, COATED PELLETS1021
67877-454-84Itraconazole3 in 1 CARTONCAPSULE, COATED PELLETS321
67877-454-90Itraconazole90 in 1 BOTTLECAPSULE, COATED PELLETS9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-454-30EA - Each67877-4546b68b905-4618-4731-a9b9-ba1829203ac612017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-454ITRACONAZOLE CAPSULE, COATED PELLETS [ASCEND LABORATORIES, LLC]18Current NDC, Legacy NDC, 5 package rows20240629_349ffcf4-b2cd-4c93-9411-13c39275b8f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311204itraconazole 100 MG Oral CapsulePSN349ffcf4-b2cd-4c93-9411-13c39275b8f321
311204itraconazole 100 MG Oral CapsuleSCD349ffcf4-b2cd-4c93-9411-13c39275b8f321
311204ICNZ 100 MG Oral CapsuleSY349ffcf4-b2cd-4c93-9411-13c39275b8f321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-454-0567877045405500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-05) 2017-12-060000-00-00NoNoCurrent
67877-454-306787704543030 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-30) 2017-12-060000-00-00NoNoCurrent
67877-454-336787704543310 in 1 BLISTER PACKHistorical
67877-454-84678770454843 BLISTER PACK in 1 CARTON (67877-454-84) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (67877-454-33) 3 blister pack2017-12-060000-00-00NoNoCurrent
67877-454-906787704549090 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-90) 2017-12-060000-00-00NoNoCurrent