NDC 68462-185

fluocinolone acetonide

Fluocinolone Acetonide

fluocinolone acetonide is a Auricular (otic) Oil in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., Usa. The primary component is Fluocinolone Acetonide.

Product ID68462-185_a00224b0-3db5-4d40-b370-5ec5476e1e10
NDC68462-185
Product TypeHuman Prescription Drug
Proprietary Namefluocinolone acetonide
Generic NameFluocinolone Acetonide
Dosage FormOil
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2018-12-18
Marketing CategoryANDA / ANDA
Application NumberANDA211815
Labeler NameGlenmark Pharmaceuticals Inc., USA
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 68462-185-56

1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) > 20 mL in 1 BOTTLE, DROPPER
Marketing Start Date2018-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68462-185-56 [68462018556]

fluocinolone acetonide OIL
Marketing CategoryANDA
Application NumberANDA211815
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-12-18

NDC 68462-185-11 [68462018511]

fluocinolone acetonide OIL
Marketing CategoryANDA
Application NumberANDA078508
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-06-18
Marketing End Date2009-11-03

NDC 68462-185-01 [68462018501]

fluocinolone acetonide OIL
Marketing CategoryANDA
Application NumberANDA078508
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-06-18
Marketing End Date2009-11-03

NDC 68462-185-05 [68462018505]

fluocinolone acetonide OIL
Marketing CategoryANDA
Application NumberANDA078508
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-06-18
Marketing End Date2009-11-03

Drug Details

Active Ingredients

IngredientStrength
FLUOCINOLONE ACETONIDE.11 mg/mL

OpenFDA Data

SPL SET ID:a00224b0-3db5-4d40-b370-5ec5476e1e10
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1191299

    • Pharmacological Class

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

    Medicade Reported Pricing

    68462018556 FLUOCINOLONE OIL 0.01% EAR DRP

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "fluocinolone acetonide" or generic name "Fluocinolone Acetonide"

    NDCBrand NameGeneric Name
    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
    68462-185fluocinolone acetonidefluocinolone acetonide
    68462-591FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDE
    68462-590FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDE
    71428-002Fluocinolone AcetonideFluocinolone Acetonide
    45802-485Fluocinolone acetonideFluocinolone acetonide
    45802-887fluocinolone acetonidefluocinolone acetonide
    45802-009Fluocinolone AcetonideFluocinolone Acetonide
    51672-1365Fluocinolone AcetonideFluocinolone Acetonide
    51672-1356Fluocinolone AcetonideFluocinolone Acetonide
    51672-1357Fluocinolone AcetonideFluocinolone Acetonide
    52565-012Fluocinolone AcetonideFluocinolone Acetonide
    52565-020Fluocinolone AcetonideFluocinolone Acetonide
    52565-013Fluocinolone AcetonideFluocinolone Acetonide
    52565-031Fluocinolone AcetonideFluocinolone Acetonide
    61748-204Fluocinolone AcetonideFluocinolone Acetonide
    61748-250Fluocinolone AcetonideFluocinolone Acetonide
    65162-702Fluocinolone AcetonideFluocinolone Acetonide
    65162-704Fluocinolone AcetonideFluocinolone Acetonide
    65162-703Fluocinolone AcetonideFluocinolone Acetonide
    0299-5500Capexfluocinolone acetonide
    39328-079Flac Otic Oilfluocinolone 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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