itraconazole

Product NDC
10147-0150
11-digit product format
101470150
Labeler code
10147
Product ID
10147-0150_78ca0c38-8960-4961-8cf0-11a40c636877
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
itraconazole
Dosage form
SOLUTION
Route
ORAL
Labeler
Patriot Pharmaceuticals, LLC
Application
NDA020657
Marketing category
NDA
Marketing start
1997-02-21
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10147-0150-1ML - Milliliter10147-015021c4db85-a106-430b-ad37-9010a82bc9d212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10147-0150ITRACONAZOLE SOLUTION [PATRIOT PHARMACEUTICALS, LLC]13Legacy NDC20250124_8e41e42c-3ae0-4091-970b-bc0086755f1d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10147-0150-110147015001150 mL in 1 BOTTLE (10147-0150-1) 150 ml2018-09-280000-00-00NoNoCurrent