NDC 0713-0324

Fluocinolone Acetonide

Fluocinolone Acetonide

Fluocinolone Acetonide is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by G&w Laboratories, Inc.. The primary component is Fluocinolone Acetonide.

Product ID0713-0324_93c16f2e-294c-1605-b02d-2b385c17cea0
NDC0713-0324
Product TypeHuman Prescription Drug
Proprietary NameFluocinolone Acetonide
Generic NameFluocinolone Acetonide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA089525
Labeler NameG&W Laboratories, Inc.
Substance NameFLUOCINOLONE ACETONIDE
Active Ingredient Strength0 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0713-0324-60

1 TUBE in 1 CARTON (0713-0324-60) > 60 g in 1 TUBE
Marketing Start Date2013-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0713-0324-15 [00713032415]

Fluocinolone Acetonide CREAM
Marketing CategoryNDA
Application NumberNDA012787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2013-12-20
Marketing End Date2020-02-29

NDC 0713-0324-60 [00713032460]

Fluocinolone Acetonide CREAM
Marketing CategoryNDA
Application NumberNDA012787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2013-12-20
Marketing End Date2020-09-30

Drug Details

Active Ingredients

IngredientStrength
FLUOCINOLONE ACETONIDE.25 mg/g

OpenFDA Data

SPL SET ID:366b294a-a842-041d-b843-3c6b39f2213b
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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