Itraconazole

Product NDC
70518-2872
11-digit product format
705182872
Labeler code
70518
Product ID
70518-2872_d7829254-0ca3-ce62-e053-2995a90a2617
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Itraconazole
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208591
Marketing category
ANDA
Marketing start
2020-09-09
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2872-02022-02-08C16284748780-1d6a99b39-fb3c-a426-e053-dadaa90af4c288e1955b-0336-4c1e-8f6d-aad0cebd7d25
70518-2872-02022-01-28C16284748780-1d6a99b39-fb3c-a426-e053-dadaa90af4c288e1955b-0336-4c1e-8f6d-aad0cebd7d25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2872-07051828720014 CAPSULE, COATED PELLETS in 1 BOTTLE, PLASTIC (70518-2872-0) 2020-09-090000-00-00NoNoCurrent