ITRACONAZOLE

Product NDC
70518-3264
11-digit product format
705183264
Labeler code
70518
Product ID
70518-3264_d07442a5-7d29-cc25-e053-2a95a90aecb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
itraconazole
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206741
Marketing category
ANDA
Marketing start
2021-11-08
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3264-02023-03-23C16284748780-1f386c649-b08a-0266-e053-dadaa90a7c1a59c18e0d-a7ed-48ad-a419-bc47a5d5aafd
70518-3264-02023-01-30C16284748780-1f386c649-b08a-0266-e053-dadaa90a7c1a59c18e0d-a7ed-48ad-a419-bc47a5d5aafd

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3264-07051832640014 CAPSULE in 1 BOTTLE, PLASTIC (70518-3264-0) 14 capsule2021-11-080000-00-00NoNoCurrent