NDC 71335-0769

fluconazole

Fluconazole

fluconazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Fluconazole.

Product ID71335-0769_66967a83-2303-49aa-843b-959e7f4d5234
NDC71335-0769
Product TypeHuman Prescription Drug
Proprietary Namefluconazole
Generic NameFluconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-04-06
Marketing CategoryANDA / ANDA
Application NumberANDA208963
Labeler NameBryant Ranch Prepack
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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71335-0769-0

4 TABLET in 1 BOTTLE (71335-0769-0)
Marketing Start Date2022-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0769-1 [71335076901]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-11
Marketing End Date2019-09-30

NDC 71335-0769-4 [71335076904]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-11
Marketing End Date2019-09-30

NDC 71335-0769-9 [71335076909]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-11
Marketing End Date2019-09-30

NDC 71335-0769-0 [71335076900]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-11
Marketing End Date2019-09-30

NDC 71335-0769-6 [71335076906]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-11
Marketing End Date2019-09-30

NDC 71335-0769-5 [71335076905]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-11
Marketing End Date2019-09-30

NDC 71335-0769-2 [71335076902]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-11
Marketing End Date2019-09-30

NDC 71335-0769-3 [71335076903]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-11
Marketing End Date2019-09-30

NDC 71335-0769-8 [71335076908]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-11
Marketing End Date2019-09-30

NDC 71335-0769-7 [71335076907]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-11
Marketing End Date2019-09-30

Drug Details

Active Ingredients

IngredientStrength
FLUCONAZOLE200 mg/1

OpenFDA Data

SPL SET ID:67af604c-928f-468b-ba27-ad45e95d3e7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197700
  • 197698
  • 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
    0054-0002FluconazoleFluconazole
    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

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