NDC 52565-017

Flurandrenolide

Flurandrenolide

Flurandrenolide is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Teligent Pharma, Inc.. The primary component is Flurandrenolide.

Product ID52565-017_25bacae9-c26d-40d7-8844-66d947ce58d6
NDC52565-017
Product TypeHuman Prescription Drug
Proprietary NameFlurandrenolide
Generic NameFlurandrenolide
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2016-12-30
Marketing CategoryANDA / ANDA
Application NumberANDA207851
Labeler NameTeligent Pharma, Inc.
Substance NameFLURANDRENOLIDE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52565-017-15

1 TUBE in 1 CARTON (52565-017-15) > 15 g in 1 TUBE
Marketing Start Date2016-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52565-017-15 [52565001715]

Flurandrenolide OINTMENT
Marketing CategoryANDA
Application NumberANDA207851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-30

NDC 52565-017-60 [52565001760]

Flurandrenolide OINTMENT
Marketing CategoryANDA
Application NumberANDA207851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-12-30

NDC 52565-017-30 [52565001730]

Flurandrenolide OINTMENT
Marketing CategoryANDA
Application NumberANDA207851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-30

Drug Details

Active Ingredients

IngredientStrength
FLURANDRENOLIDE.5 mg/g

OpenFDA Data

SPL SET ID:14709d5d-186c-41f1-a7cc-e08872ad6e28
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197720

    • Pharmacological Class

    • 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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