Itraconazole

Product NDC
70518-3559
11-digit product format
705183559
Labeler code
70518
Product ID
70518-3559_f0e807f9-9a93-eee6-e053-2a95a90a9f73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Itraconazole
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209460
Marketing category
ANDA
Marketing start
2022-10-21
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3559-07051835590014 CAPSULE in 1 BOTTLE, PLASTIC (70518-3559-0) 14 capsule2022-10-210000-00-00NoNoCurrent