NDC 25021-113

Fluconazole

Fluconazole

Fluconazole is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sagent Pharmaceuticals. The primary component is Fluconazole.

Product ID25021-113_970858ed-806f-4143-919a-27341227bd8a
NDC25021-113
Product TypeHuman Prescription Drug
Proprietary NameFluconazole
Generic NameFluconazole
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2009-09-01
Marketing End Date2021-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA079104
Labeler NameSagent Pharmaceuticals
Substance NameFLUCONAZOLE
Active Ingredient Strength2 mg/mL
Pharm ClassesAzole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 25021-113-82

10 POUCH in 1 CARTON (25021-113-82) > 1 BAG in 1 POUCH > 100 mL in 1 BAG
Marketing Start Date2009-09-01
Marketing End Date2021-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25021-113-82 [25021011382]

Fluconazole INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA079104
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-09-01
Marketing End Date2021-05-31

NDC 25021-113-87 [25021011387]

Fluconazole INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA079104
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-09-01
Marketing End Date2021-03-31

Drug Details

Active Ingredients

IngredientStrength
FLUCONAZOLE2 mg/mL

OpenFDA Data

SPL SET ID:b0172db6-fd8d-4ef3-873d-6c4de6538454
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1721314
  • 1721315
    • UPC Code
  • 0325021113820

    • 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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