Itraconazole

Product NDC
49884-239
11-digit product format
498840239
Labeler code
49884
Product ID
49884-239_a72890ec-d1bc-474d-ba59-e8efb7de6eac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Itraconazole
Dosage form
CAPSULE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA205724
Marketing category
ANDA
Marketing start
2016-07-01
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
49884-239-11EA - Each49884-23965196caa-96c0-4fbf-ac5f-4adc2d9260db12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-239ITRACONAZOLE CAPSULE [PAR PHARMACEUTICAL, INC.]11Legacy NDC20230913_8d34a00f-f6f9-4bd5-9cba-505038d15c46.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-239-114988402391130 CAPSULE in 1 BOTTLE (49884-239-11) 30 capsule2016-07-010000-00-00NoNoCurrent