FDA.reportPublic FDA data

itraconazole

Product NDC
10147-1700
11-digit product format
101471700
Labeler code
10147
Product ID
10147-1700_2cca3625-96e8-34cf-e063-6294a90ac975
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ITRACONAZOLE
Dosage form
CAPSULE
Route
ORAL
Labeler
Patriot Pharmaceuticals
Application
NDA020083
Marketing category
NDA
Marketing start
2005-02-01
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
10147-1700-3itraconazole30 in 1 BOTTLECAPSULE3028
10147-1700-7itraconazole7 in 1 DOSE PACKCAPSULE728
10147-1700-7itraconazole1 in 1 POUCHCAPSULE128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10147-1700-3EA - Each10147-170089c909d7-def8-4d66-aab6-324b7455725f12012-07-24
10147-1700-7EA - Each10147-17006ac2f584-c34a-4a87-9993-740e0c4ed27c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ITRACONAZOLEACTIVE INGREDIENT304NUG5GF4ITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]9
ITRACONAZOLEACTIVE MOIETY304NUG5GF4ITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]9
D&C Red No. 22INACTIVE INGREDIENT1678RKX8RTITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]9
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]9
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]9
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]9
GELATININACTIVE INGREDIENT2G86QN327LITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]9
starch, cornINACTIVE INGREDIENTO8232NY3SJITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]9
SUCROSEINACTIVE INGREDIENTC151H8M554ITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]9
ITRACONAZOLEACTIVE INGREDIENT304NUG5GF4ITRACONAZOLE CAPSULE [CARILION MATERIALS MANAGEMENT]2
ITRACONAZOLEACTIVE MOIETY304NUG5GF4ITRACONAZOLE CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RTITRACONAZOLE CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHITRACONAZOLE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDITRACONAZOLE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKITRACONAZOLE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LITRACONAZOLE CAPSULE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOITRACONAZOLE CAPSULE [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AITRACONAZOLE CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJITRACONAZOLE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SUCROSEINACTIVE INGREDIENTC151H8M554ITRACONAZOLE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPITRACONAZOLE CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10147-1700ITRACONAZOLE CAPSULE [PATRIOT PHARMACEUTICALS]28Current NDC, Legacy NDC, 3 package rows20250130_6242b7ad-eaa0-a524-b6e0-ec33e63407db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311204itraconazole 100 MG Oral CapsulePSN6242b7ad-eaa0-a524-b6e0-ec33e63407db28
311204itraconazole 100 MG Oral CapsuleSCD6242b7ad-eaa0-a524-b6e0-ec33e63407db28
311204ICNZ 100 MG Oral CapsuleSY6242b7ad-eaa0-a524-b6e0-ec33e63407db28
311204itraconazole 100 MG Oral CapsulePSN31735974-a7ac-42b5-8ce1-4d8dc2808c3a3
311204itraconazole 100 MG Oral CapsuleSCD31735974-a7ac-42b5-8ce1-4d8dc2808c3a3
311204ICNZ 100 MG Oral CapsuleSY31735974-a7ac-42b5-8ce1-4d8dc2808c3a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10147-1700-31014717000330 CAPSULE in 1 BOTTLE (10147-1700-3) 30 capsule2005-02-010000-00-00NoNoCurrent
10147-1700-7101471700077 POUCH in 1 DOSE PACK (10147-1700-7) > 1 BLISTER PACK in 1 POUCH > 4 CAPSULE in 1 BLISTER PACK7 pouch2005-02-010000-00-00NoNoCurrent