NDC 0713-0709

FLUOCINOLONE ACETONIDE

Fluocinolone Acetonide

FLUOCINOLONE ACETONIDE is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Cosette Pharmaceuticals, Inc.. The primary component is Fluocinolone Acetonide.

Product ID0713-0709_3c99b25f-031a-4f38-bdcc-7d847fc58bf2
NDC0713-0709
Product TypeHuman Prescription Drug
Proprietary NameFLUOCINOLONE ACETONIDE
Generic NameFluocinolone Acetonide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-11-05
Marketing CategoryANDA / ANDA
Application NumberANDA210747
Labeler NameCosette Pharmaceuticals, Inc.
Substance NameFLUOCINOLONE ACETONIDE
Active Ingredient Strength0 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0713-0709-15

1 TUBE in 1 CARTON (0713-0709-15) > 15 g in 1 TUBE
Marketing Start Date2018-11-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0713-0709-60 [00713070960]

FLUOCINOLONE ACETONIDE CREAM
Marketing CategoryANDA
Application NumberANDA210747
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-11-05

NDC 0713-0709-15 [00713070915]

FLUOCINOLONE ACETONIDE CREAM
Marketing CategoryANDA
Application NumberANDA210747
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-11-05

Drug Details

Active Ingredients

IngredientStrength
FLUOCINOLONE ACETONIDE.25 mg/g

OpenFDA Data

SPL SET ID:a6e77bc5-ddb3-491a-bf16-d6d253886bb0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1191315
  • Pharmacological Class

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

    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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