Itraconazole

Product NDC
16729-271
11-digit product format
167290271
Labeler code
16729
Product ID
16729-271_ecb5f481-5b97-3973-e053-2995a90a9d04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ITRACONAZOLE
Dosage form
CAPSULE
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA205991
Marketing category
ANDA
Marketing start
2017-05-30
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-271-10EA - Each16729-271181a84c8-6bd6-4603-b51b-5f4b5d91466812017-06-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-271-101672902711030 CAPSULE in 1 BOTTLE (16729-271-10) 30 capsule2017-05-300000-00-00NoNoCurrent