NDC 68791-103

DermOtic

Fluocinolone Acetonide

DermOtic is a Auricular (otic) Oil in the Human Prescription Drug category. It is labeled and distributed by Royal Pharmaceuticals. The primary component is Fluocinolone Acetonide.

Product ID68791-103_1de3ab34-48ce-40ca-89a8-651c572ef8f2
NDC68791-103
Product TypeHuman Prescription Drug
Proprietary NameDermOtic
Generic NameFluocinolone Acetonide
Dosage FormOil
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2005-11-09
Marketing CategoryNDA / NDA
Application NumberNDA019452
Labeler NameRoyal Pharmaceuticals
Substance NameFLUOCINOLONE ACETONIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68791-103-20

1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) > 20 mL in 1 BOTTLE, DROPPER
Marketing Start Date2005-11-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68791-103-20 [68791010320]

DermOtic OIL
Marketing CategoryNDA
Application NumberNDA019452
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-11-09

Drug Details

Active Ingredients

IngredientStrength
FLUOCINOLONE ACETONIDE.11 mg/mL

OpenFDA Data

SPL SET ID:eb00f222-8105-4e05-90e8-bbd129784364
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1191301
  • 1191299

    • Pharmacological Class

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

    Medicade Reported Pricing

    68791010320 DERMOTIC OIL 0.01% EAR DROPS

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "DermOtic" or generic name "Fluocinolone Acetonide"

    NDCBrand NameGeneric Name
    68791-103DermOticDermOtic
    0299-5500Capexfluocinolone acetonide
    39328-079Flac Otic Oilfluocinolone acetonide
    0168-0058Fluocinolone Acetonidefluocinolone acetonide
    0168-0059Fluocinolone Acetonidefluocinolone acetonide
    0168-0060Fluocinolone Acetonidefluocinolone acetonide
    0168-0064Fluocinolone Acetonidefluocinolone acetonide
    0713-0223Fluocinolone AcetonideFluocinolone Acetonide
    0713-0224Fluocinolone AcetonideFluocinolone Acetonide
    0713-0324Fluocinolone AcetonideFluocinolone Acetonide
    0713-0325Fluocinolone AcetonideFluocinolone Acetonide
    0713-0709FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDE
    10135-670fluocinolone acetonidefluocinolone acetonide
    13925-506Fluocinolone Acetonidefluocinolone acetonide
    13925-507Fluocinolone Acetonidefluocinolone acetonide
    42291-283Fluocinolone AcetonideFluocinolone Acetonide
    42291-284Fluocinolone AcetonideFluocinolone Acetonide
    42291-285Fluocinolone AcetonideFluocinolone Acetonide
    43386-069Fluocinolone AcetonideFluocinolone Acetonide
    13925-508Fluocinolone acetonide 0.01%fluocinolone acetonide
    24208-416RetisertFluocinolone Acetonide
    43538-900Synalarfluocinolone acetonide
    43538-901SynalarFluocinolone acetonide
    43538-910Synalarfluocinolone acetonide
    43538-911SynalarFluocinolone acetonide
    43538-920Synalarfluocinolone acetonide
    43538-921Synalar TSfluocinolone acetonide

    Trademark Results [DermOtic]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DERMOTIC
    DERMOTIC
    78688102 3170129 Live/Registered
    Hill Dermaceuticals, Inc.
    2005-08-08
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