NDC 70518-0671

Flunisolide

Flunisolide

Flunisolide is a Nasal Solution in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Flunisolide.

Product ID70518-0671_6c325112-2d53-46e2-e053-2a91aa0a2920
NDC70518-0671
Product TypeHuman Prescription Drug
Proprietary NameFlunisolide
Generic NameFlunisolide
Dosage FormSolution
Route of AdministrationNASAL
Marketing Start Date2017-08-18
Marketing CategoryANDA / ANDA
Application NumberANDA074805
Labeler NameREMEDYREPACK INC.
Substance NameFLUNISOLIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-0671-0

25 mL in 1 BOTTLE, PUMP (70518-0671-0)
Marketing Start Date2017-08-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0671-0 [70518067100]

Flunisolide SOLUTION
Marketing CategoryANDA
Application NumberANDA074805
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FLUNISOLIDE.25 mg/mL

OpenFDA Data

SPL SET ID:34aea106-c7f3-4324-baa9-d6fd3028b108
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797863
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Flunisolide" or generic name "Flunisolide"

    NDCBrand NameGeneric Name
    24208-344FlunisolideFlunisolide
    50742-317FlunisolideFlunisolide
    64980-510FlunisolideFlunisolide
    70518-0671FlunisolideFlunisolide
    0037-7590Aerospanflunisolide

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