NDC 12634-780

Fluconazole

Fluconazole

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

Product ID12634-780_277154a2-2784-3775-e054-00144ff88e88
NDC12634-780
Product TypeHuman Prescription Drug
Proprietary NameFluconazole
Generic NameFluconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-10-07
Marketing CategoryANDA / ANDA
Application NumberANDA077731
Labeler NameApotheca Inc.
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 Through2019-12-31

Packaging

NDC 12634-780-60

60 TABLET in 1 BOTTLE (12634-780-60)
Marketing Start Date2008-10-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-780-93 [12634078093]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA077731
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-07
Inactivation Date2020-01-31

NDC 12634-780-92 [12634078092]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA077731
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-07
Inactivation Date2020-01-31

NDC 12634-780-91 [12634078091]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA077731
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-07
Inactivation Date2020-01-31

NDC 12634-780-76 [12634078076]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA077731
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-07
Inactivation Date2020-01-31

NDC 12634-780-60 [12634078060]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA077731
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-07
Inactivation Date2020-01-31

NDC 12634-780-01 [12634078001]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA077731
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-07
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FLUCONAZOLE150 mg/1

OpenFDA Data

SPL SET ID:277154a2-2783-3775-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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
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