NDC 39328-079

Flac Otic Oil

Fluocinolone Acetonide

Flac Otic Oil is a Auricular (otic) Oil in the Human Prescription Drug category. It is labeled and distributed by Patrin Pharma, Inc.. The primary component is Fluocinolone Acetonide.

Product ID39328-079_5d3d3dcc-d669-40b4-8bed-48415a2a4df1
NDC39328-079
Product TypeHuman Prescription Drug
Proprietary NameFlac Otic Oil
Generic NameFluocinolone Acetonide
Dosage FormOil
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2018-04-12
Marketing CategoryANDA / ANDA
Application NumberANDA210736
Labeler NamePatrin Pharma, Inc.
Substance NameFLUOCINOLONE ACETONIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 39328-079-20

1 BOTTLE, DROPPER in 1 CARTON (39328-079-20) > 20 mL in 1 BOTTLE, DROPPER
Marketing Start Date2018-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 39328-079-20 [39328007920]

Flac Otic Oil OIL
Marketing CategoryANDA
Application NumberANDA210736
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-04-12

Drug Details

Active Ingredients

IngredientStrength
FLUOCINOLONE ACETONIDE.11 mg/mL

OpenFDA Data

SPL SET ID:4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2045201
  • 1191299
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Flac Otic Oil" or generic name "Fluocinolone Acetonide"

    NDCBrand NameGeneric Name
    39328-079Flac Otic Oilfluocinolone acetonide
    0299-5500Capexfluocinolone 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

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