NDC 45802-928

Flurandrenolide

Flurandrenolide

Flurandrenolide is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is Flurandrenolide.

Product ID45802-928_29584c9c-4346-4e70-abb2-9eff7698e1c1
NDC45802-928
Product TypeHuman Prescription Drug
Proprietary NameFlurandrenolide
Generic NameFlurandrenolide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2016-10-06
Marketing CategoryANDA / ANDA
Application NumberANDA207133
Labeler NamePadagis Israel Pharmaceuticals Ltd
Substance NameFLURANDRENOLIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 45802-928-03

1 BOTTLE, PLASTIC in 1 CARTON (45802-928-03) > 120 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2016-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45802-928-03 [45802092803]

Flurandrenolide LOTION
Marketing CategoryANDA
Application NumberANDA207133
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-10-06

Drug Details

Active Ingredients

IngredientStrength
FLURANDRENOLIDE.5 mg/mL

OpenFDA Data

SPL SET ID:9c4f5aea-2e08-400c-88f6-d9e3013afda7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197719

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    24470-921FlurandrenolideFLURANDRENOLIDE
    45802-928FlurandrenolideFlurandrenolide
    51672-5298FlurandrenolideFlurandrenolide
    51672-5301FlurandrenolideFlurandrenolide
    51862-158flurandrenolideflurandrenolide
    52565-017FlurandrenolideFlurandrenolide
    63629-8657FlurandrenolideFlurandrenolide
    0023-5870CordranFlurandrenolide
    16110-026Cordranflurandrenolide
    16110-034Cordranflurandrenolide
    16110-035Cordranflurandrenolide
    16110-052Cordranflurandrenolide
    16110-587CORDRANflurandrenolide
    24470-919Flurandrenolide CreamFLURANDRENOLIDE
    57893-310NolixFLURANDRENOLIDE
    57893-311NolixFLURANDRENOLIDE
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