NDC 0409-4688

Fluconazole in Sodium Chloride

Fluconazole In Sodium Chloride

Fluconazole in Sodium Chloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Fluconazole.

Product ID0409-4688_14c76263-9b4d-421d-bca8-e3bf91ca5116
NDC0409-4688
Product TypeHuman Prescription Drug
Proprietary NameFluconazole in Sodium Chloride
Generic NameFluconazole In Sodium Chloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2006-04-17
Marketing CategoryANDA / ANDA
Application NumberANDA076303
Labeler NameHospira, Inc.
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
Listing Certified Through2019-12-31

Packaging

NDC 0409-4688-12

24 BAG in 1 CASE (0409-4688-12) > 200 mL in 1 BAG (0409-4688-16)
Marketing Start Date2015-10-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-4688-54 [00409468854]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Marketing End Date2014-12-05

NDC 0409-4688-02 [00409468802]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-07-05
Marketing End Date2016-11-01

NDC 0409-4688-16 [00409468816]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-12-05

NDC 0409-4688-29 [00409468829]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-12-05
Marketing End Date2019-04-29

NDC 0409-4688-06 [00409468806]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-12-05
Marketing End Date2019-04-29

NDC 0409-4688-27 [00409468827]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-07-01
Marketing End Date2013-06-10

NDC 0409-4688-13 [00409468813]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Marketing End Date2014-12-05

NDC 0409-4688-23 [00409468823]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-04-17
Marketing End Date2017-01-01

NDC 0409-4688-33 [00409468833]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-07-01
Marketing End Date2013-06-10

NDC 0409-4688-12 [00409468812]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-21

NDC 0409-4688-28 [00409468828]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-07-29
Marketing End Date2015-12-01

NDC 0409-4688-34 [00409468834]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-07-29
Marketing End Date2016-02-01

NDC 0409-4688-18 [00409468818]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-12-18

NDC 0409-4688-22 [00409468822]

Fluconazole in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-12-05

Drug Details

Active Ingredients

IngredientStrength
FLUCONAZOLE2 mg/mL

OpenFDA Data

SPL SET ID:b3efaffa-9ef9-4a4f-998e-aa7d2eb61fc9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1721314
  • 1721315
  • 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 in Sodium Chloride" or generic name "Fluconazole In Sodium Chloride"

    NDCBrand NameGeneric Name
    0409-4688Fluconazole in Sodium ChlorideFluconazole in Sodium Chloride
    69784-002Fluconazole in Sodium ChlorideFluconazole, Sodium Chloride
    69784-003Fluconazole in Sodium ChlorideFluconazole, Sodium Chloride
    69784-261Fluconazole in Sodium ChlorideFluconazole, Sodium Chloride
    70655-002Fluconazole in Sodium ChlorideFluconazole, Sodium Chloride
    70655-088Fluconazole in Sodium ChlorideFluconazole, Sodium Chloride

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