KETOCONAZOLE

Product NDC
70518-2315
11-digit product format
705182315
Labeler code
70518
Product ID
70518-2315_c83189de-e7ed-dea0-e053-2995a90ac745
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOCONAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210457
Marketing category
ANDA
Marketing start
2019-09-16
Marketing end
0000-00-00
Substance
KETOCONAZOLE
Active strength
200 mg/1
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein 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
70518-2315-02023-03-09C16284748780-1f386c64a-3331-0266-e053-dadaa90a7c1a0d12b5f7-0f03-46d3-acdd-0e397133e6c3
70518-2315-02023-01-30C16284748780-1f386c64a-3331-0266-e053-dadaa90a7c1a0d12b5f7-0f03-46d3-acdd-0e397133e6c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2315-07051823150030 TABLET in 1 BLISTER PACK (70518-2315-0) 30 tablet2019-09-160000-00-00NoNoCurrent