fluconazole

Product NDC
70518-2411
11-digit product format
705182411
Labeler code
70518
Product ID
70518-2411_ea36ea99-2b38-5967-e053-2a95a90a0b60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208963
Marketing category
ANDA
Marketing start
2019-11-10
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
200 mg/1
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2411-07051824110030 TABLET in 1 BLISTER PACK (70518-2411-0) 30 tablet2019-11-100000-00-00NoNoCurrent
70518-2411-1705182411012 TABLET in 1 BOTTLE, PLASTIC (70518-2411-1) 2 tablet2022-02-140000-00-00NoNoCurrent
70518-2411-2705182411024 TABLET in 1 BOTTLE, PLASTIC (70518-2411-2) 4 tablet2022-10-030000-00-00NoNoCurrent