NDC 52565-025

Fluocinonide

Fluocinonide

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

Product ID52565-025_6c386170-5e59-468f-a170-8b7a41124864
NDC52565-025
Product TypeHuman Prescription Drug
Proprietary NameFluocinonide
Generic NameFluocinonide
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2019-03-18
Marketing CategoryANDA / ANDA
Application NumberANDA207554
Labeler NameTeligent Pharma, Inc.
Substance NameFLUOCINONIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52565-025-20

1 BOTTLE in 1 CARTON (52565-025-20) > 20 mL in 1 BOTTLE
Marketing Start Date2019-03-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52565-025-20 [52565002520]

Fluocinonide SOLUTION
Marketing CategoryANDA
Application NumberANDA207554
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-18

NDC 52565-025-59 [52565002559]

Fluocinonide SOLUTION
Marketing CategoryANDA
Application NumberANDA207554
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-18

Drug Details

Active Ingredients

IngredientStrength
FLUOCINONIDE.5 mg/mL

OpenFDA Data

SPL SET ID:edd2e419-44b0-4b7b-9037-d5cbd5d3b63c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310364
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-0262FluocinonideFluocinonide
    0093-0263FluocinonideFluocinonide
    0093-0264FluocinonideFluocinonide
    0115-1705FluocinonideFluocinonide
    0115-1706FluocinonideFluocinonide
    0115-1707FluocinonideFluocinonide
    0168-0134fluocinonidefluocinonide
    0168-0135Fluocinonidefluocinonide
    0168-0139Fluocinonidefluocinonide
    0168-0140Fluocinonidefluocinonide
    0168-0246fluocinonidefluocinonide
    0168-0457fluocinonidefluocinonide
    0472-0829FluocinonideFluocinonide
    0713-0663FluocinonideFluocinonide
    0713-0664FluocinonideFluocinonide
    0713-0803FluocinonideFluocinonide
    16714-502FluocinonideFluocinonide
    21695-979FluocinonideFluocinonide
    21922-001Fluocinonidefluocinonide topical solution usp, 0.05%
    33261-560FluocinonideFluocinonide
    33342-320FluocinonideFluocinonide
    40032-026fluocinonidefluocinonide
    40032-095FluocinonideFluocinonide
    43199-029FluocinonideFluocinonide
    43199-031FluocinonideFluocinonide
    43386-026FluocinonideFluocinonide
    43386-095FluocinonideFluocinonide
    45802-151FluocinonideFluocinonide
    68071-1754FluocinonideFluocinonide
    68071-1654FluocinonideFluocinonide
    68071-3213FluocinonideFluocinonide
    68071-4219FluocinonideFluocinonide
    68071-3322FluocinonideFluocinonide
    68071-4507FluocinonideFluocinonide
    68071-4619FluocinonideFluocinonide
    68071-4732FluocinonideFluocinonide
    68462-505FluocinonideFluocinonide
    68788-6350FluocinonideFluocinonide
    68682-992FluocinonideFluocinonide
    68788-0139FluocinonideFluocinonide
    68788-7041FluocinonideFluocinonide
    68788-9381FluocinonideFluocinonide
    68788-7260FluocinonideFluocinonide
    69238-1271FluocinonideFluocinonide
    70518-0853FluocinonideFluocinonide
    70771-1375FluocinonideFluocinonide
    70710-1284FluocinonideFluocinonide
    71085-006FluocinonideFluocinonide
    71085-004FluocinonideFluocinonide
    71205-092FluocinonideFluocinonide

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