NDC 70771-1065

fluconazole

Fluconazole

fluconazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Fluconazole.

Product ID70771-1065_521d0ea1-b548-40e5-a7f1-ab1b65537b3b
NDC70771-1065
Product TypeHuman Prescription Drug
Proprietary Namefluconazole
Generic NameFluconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-04-06
Marketing CategoryANDA / ANDA
Application NumberANDA208963
Labeler NameCadila Healthcare Limited
Substance NameFLUCONAZOLE
Active Ingredient Strength150 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 70771-1065-1

100 TABLET in 1 BOTTLE (70771-1065-1)
Marketing Start Date2017-04-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1065-7 [70771106507]

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

NDC 70771-1065-8 [70771106508]

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

NDC 70771-1065-1 [70771106501]

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

NDC 70771-1065-5 [70771106505]

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

NDC 70771-1065-3 [70771106503]

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

Drug Details

Active Ingredients

IngredientStrength
FLUCONAZOLE150 mg/1

OpenFDA Data

SPL SET ID:0adb2f88-8a6f-4f33-9e2d-73f537e05313
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197700
  • 197701
  • 197698
  • 197699
    • UPC Code
  • 0370771106516
  • 0370771106615
  • 0370771106578
  • 0370771106318
  • 0370771106417

    • 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]

    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
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