FDA.reportPublic FDA data

ITRACONAZOLE

Product NDC
62332-204
11-digit product format
623320204
Labeler code
62332
Product ID
62332-204_585449d8-bba8-44fb-9544-e83636d972e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
itraconazole
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA206741
Marketing category
ANDA
Marketing start
2016-12-16
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
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
62332-204-04ITRACONAZOLE28 in 1 CARTONCAPSULE2825
62332-204-10ITRACONAZOLE100 in 1 CARTONCAPSULE10025
62332-204-30ITRACONAZOLE30 in 1 BOTTLECAPSULE3025
62332-204-71ITRACONAZOLE500 in 1 BOTTLECAPSULE50025
62332-204-90ITRACONAZOLE90 in 1 BOTTLECAPSULE9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-204-04EA - Each62332-20405946fed-beae-4ba6-b0b0-3c3050e3ea1112018-03-08
62332-204-30EA - Each62332-204802aba23-7e70-463c-9f4a-f3bd0d6f68d312017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-204ITRACONAZOLE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]25Current NDC, Legacy NDC, 5 package rows20250323_23126370-8d6a-4027-bd8f-860e2776ba3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311204itraconazole 100 MG Oral CapsulePSN23126370-8d6a-4027-bd8f-860e2776ba3a25
311204itraconazole 100 MG Oral CapsuleSCD23126370-8d6a-4027-bd8f-860e2776ba3a25
311204ICNZ 100 MG Oral CapsuleSY23126370-8d6a-4027-bd8f-860e2776ba3a25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-204-046233202040428 CAPSULE in 1 CARTON (62332-204-04) 28 capsule2016-12-160000-00-00NoNoCurrent
62332-204-1062332020410100 CAPSULE in 1 CARTON (62332-204-10) 100 capsule2016-12-160000-00-00NoNoCurrent
62332-204-306233202043030 CAPSULE in 1 BOTTLE (62332-204-30) 30 capsule2016-12-160000-00-00NoNoCurrent
62332-204-7162332020471500 CAPSULE in 1 BOTTLE (62332-204-71) 500 capsule2016-12-160000-00-00NoNoCurrent
62332-204-906233202049090 CAPSULE in 1 BOTTLE (62332-204-90) 90 capsule2016-12-160000-00-00NoNoCurrent