NDC 70710-1138

fluconazole

Fluconazole

fluconazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Fluconazole.

Product ID70710-1138_73a09b81-584b-4fed-8d2c-82935588d03c
NDC70710-1138
Product TypeHuman Prescription Drug
Proprietary Namefluconazole
Generic NameFluconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-04-06
Marketing CategoryANDA / ANDA
Application NumberANDA208963
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameFLUCONAZOLE
Active Ingredient Strength100 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 Through2022-12-31

Packaging

NDC 70710-1138-1

100 TABLET in 1 BOTTLE (70710-1138-1)
Marketing Start Date2017-04-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70710-1138-3 [70710113803]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-06

NDC 70710-1138-4 [70710113804]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-06

NDC 70710-1138-1 [70710113801]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-06

NDC 70710-1138-5 [70710113805]

fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA208963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-06

Drug Details

Active Ingredients

IngredientStrength
FLUCONAZOLE100 mg/1

OpenFDA Data

SPL SET ID:d1364455-1537-46d4-b093-38cca3be778f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197700
  • 197701
  • 197698
  • 197699
  • UPC Code
  • 0370710113834
  • 0370710114039
  • 0370710113735
  • 0370710113971
  • 0370710113933
  • Pharmacological Class

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

    Medicade Reported Pricing

    70710113803 FLUCONAZOLE 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    70710113801 FLUCONAZOLE 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    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.