NDC 68788-9927

Fluconazole

Fluconazole

Fluconazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Fluconazole.

Product ID68788-9927_7636b432-53df-44f3-aeb1-e3abc9812bd1
NDC68788-9927
Product TypeHuman Prescription Drug
Proprietary NameFluconazole
Generic NameFluconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-01-18
Marketing CategoryANDA / ANDA
Application NumberANDA076077
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NameFLUCONAZOLE
Active Ingredient Strength200 mg/1
Pharm ClassesAzole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68788-9927-0

1 TABLET in 1 BOTTLE (68788-9927-0)
Marketing Start Date2012-01-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9927-5 [68788992705]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA076077
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-20

NDC 68788-9927-3 [68788992703]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA076077
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-20

NDC 68788-9927-9 [68788992709]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA076077
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-20

NDC 68788-9927-0 [68788992700]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA076077
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-20

NDC 68788-9927-2 [68788992702]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA076077
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-20

NDC 68788-9927-1 [68788992701]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA076077
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-20

NDC 68788-9927-6 [68788992706]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA076077
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-20

Drug Details

Active Ingredients

IngredientStrength
FLUCONAZOLE200 mg/1

OpenFDA Data

SPL SET ID:49421564-d2d3-4f69-93b2-bd9eec7feb8f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197700
  • 197699

    • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]
    • Cytochrome P450 2C19 Inhibitors [MoA]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 2C9 Inhibitors [MoA]

    NDC Crossover Matching brand name "Fluconazole" or generic name "Fluconazole"

    NDCBrand NameGeneric Name
    68001-253FluconazoleFluconazole
    68001-251FluconazoleFluconazole
    68001-254FluconazoleFluconazole
    68001-252FluconazoleFluconazole
    68071-1863FluconazoleFluconazole
    68071-3344FluconazoleFluconazole
    68071-4437fluconazolefluconazole
    68071-4501fluconazolefluconazole
    68071-4386fluconazolefluconazole
    68071-4651FluconazoleFluconazole
    68084-728FluconazoleFluconazole
    68084-735FluconazoleFluconazole
    68258-3036FluconazoleFluconazole
    68462-101FluconazoleFluconazole
    68462-104FluconazoleFluconazole
    68462-102FluconazoleFluconazole
    68462-103FluconazoleFluconazole
    68788-2518FluconazoleFluconazole
    68788-7045FluconazoleFluconazole
    68788-7293FluconazoleFluconazole
    68788-7060FluconazoleFluconazole
    68788-9245FluconazoleFluconazole
    68788-7203fluconazolefluconazole
    68788-8963FluconazoleFluconazole
    68788-7150fluconazolefluconazole
    68788-8938FluconazoleFluconazole
    68788-9927FluconazoleFluconazole
    68788-9190FluconazoleFluconazole
    68788-9988FluconazoleFluconazole
    68788-9926FluconazoleFluconazole
    69189-5016FluconazoleFluconazole
    70518-0007FluconazoleFluconazole
    70518-0562FluconazoleFluconazole
    70518-0560FluconazoleFluconazole
    70710-1139fluconazolefluconazole
    70710-1137fluconazolefluconazole
    70771-1065fluconazolefluconazole
    70771-1066fluconazolefluconazole
    70771-1063fluconazolefluconazole
    70710-1138fluconazolefluconazole
    70710-1140fluconazolefluconazole
    70771-1064fluconazolefluconazole
    71205-104FluconazoleFluconazole
    71205-081fluconazolefluconazole
    71205-094FluconazoleFluconazole
    71335-0764FluconazoleFluconazole
    71335-0769fluconazolefluconazole
    71335-0686fluconazolefluconazole
    71335-1037FluconazoleFluconazole
    71335-0557FluconazoleFluconazole
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.