NDC 71205-094

Fluconazole

Fluconazole

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

Product ID71205-094_350219f7-f96b-4890-a20d-cb8c25084825
NDC71205-094
Product TypeHuman Prescription Drug
Proprietary NameFluconazole
Generic NameFluconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-03-07
Marketing CategoryANDA / ANDA
Application NumberANDA078423
Labeler NameProficient Rx LP
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 Through2019-12-31

Packaging

NDC 71205-094-01

1 TABLET in 1 BOTTLE (71205-094-01)
Marketing Start Date2018-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71205-094-02 [71205009402]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA078423
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-01

NDC 71205-094-04 [71205009404]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA078423
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-01

NDC 71205-094-30 [71205009430]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA078423
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-01

NDC 71205-094-01 [71205009401]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA078423
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-01

NDC 71205-094-03 [71205009403]

Fluconazole TABLET
Marketing CategoryANDA
Application NumberANDA078423
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-01

Drug Details

Active Ingredients

IngredientStrength
FLUCONAZOLE100 mg/1

OpenFDA Data

SPL SET ID:2a0076e4-4f1a-47a4-9b3c-c2ecac50424a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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
    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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