itraconazole

Product NDC
59746-282
11-digit product format
597460282
Labeler code
59746
Product ID
59746-282_d4ae4f65-2b9e-425c-aa9c-7743b47f5bb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Itraconazole Capsules
Dosage form
CAPSULE
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA203445
Marketing category
ANDA
Marketing start
2017-02-23
Marketing end
0000-00-00
Substance
ITRACONAZOLE
Active strength
100 mg/1
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-282-30EA - Each59746-282ea7c3641-6a9b-4e12-8c26-88e32ccf09cc12017-10-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-282-22597460282227 BLISTER PACK in 1 CARTON (59746-282-22) > 4 CAPSULE in 1 BLISTER PACK7 blister pack2017-02-230000-00-00NoNoCurrent
59746-282-305974602823030 CAPSULE in 1 BOTTLE (59746-282-30) 30 capsule2017-02-230000-00-00NoNoCurrent