FDA.reportPublic FDA data

Itraconazole

Product NDC
50268-450
11-digit product format
502680450
Labeler code
50268
Product ID
50268-450_4823fc2f-1a82-9e54-e063-6294a90abb18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Itraconazole
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA205080
Marketing category
ANDA
Marketing start
2018-03-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Itraconazole
Listing expiration
2027-12-31

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-450-11Itraconazole1 in 1 BLISTER PACKCAPSULE117
50268-450-12Itraconazole20 in 1 BOX, UNIT-DOSECAPSULE2017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-450-11EA - Each50268-4502ef1f8e5-c1bb-4a41-8cab-4748c886d0b612018-05-09
50268-450-12EA - Each50268-4508c62df80-4850-4659-9e54-06ea7343e3b712018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-450ITRACONAZOLE CAPSULE [AVPAK]15Current NDC, Legacy NDC, 2 package rows20240110_68165d90-953c-e2f5-e053-2a91aa0ada25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311204itraconazole 100 MG Oral CapsulePSN68165d90-953c-e2f5-e053-2a91aa0ada2517
311204itraconazole 100 MG Oral CapsuleSCD68165d90-953c-e2f5-e053-2a91aa0ada2517
311204ICNZ 100 MG Oral CapsuleSY68165d90-953c-e2f5-e053-2a91aa0ada2517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-450-11502680450111 in 1 BLISTER PACKHistorical
50268-450-125026804501220 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-450-12) / 1 CAPSULE in 1 BLISTER PACK (50268-450-11) 20 blister pack2018-03-230000-00-00NoNoCurrent