NDC 0023-5861

GELNIQUE

Oxybutynin Chloride

GELNIQUE is a Transdermal Gel in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Oxybutynin Chloride.

Product ID0023-5861_74ccc9f4-e4c5-472a-9087-39389aefda50
NDC0023-5861
Product TypeHuman Prescription Drug
Proprietary NameGELNIQUE
Generic NameOxybutynin Chloride
Dosage FormGel
Route of AdministrationTRANSDERMAL
Marketing Start Date2017-04-01
Marketing CategoryNDA / NDA
Application NumberNDA022204
Labeler NameAllergan, Inc.
Substance NameOXYBUTYNIN CHLORIDE
Active Ingredient Strength100 mg/g
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0023-5861-11

30 PACKET in 1 CARTON (0023-5861-11) > 1 g in 1 PACKET
Marketing Start Date2017-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0023-5861-11 [00023586111]

GELNIQUE GEL
Marketing CategoryNDA
Application NumberNDA022204
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-04-01

Drug Details

Active Ingredients

IngredientStrength
OXYBUTYNIN CHLORIDE100 mg/g

OpenFDA Data

SPL SET ID:57616d79-9e68-4ec7-a25f-ebee07576351
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864820
  • 864818
  • Pharmacological Class

    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]
    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]

    NDC Crossover Matching brand name "GELNIQUE" or generic name "Oxybutynin Chloride"

    NDCBrand NameGeneric Name
    0023-5812GELNIQUEoxybutynin chloride
    0023-5861GELNIQUEoxybutynin chloride
    52544-084GELNIQUEGELNIQUE
    0093-5206OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE
    0093-5207OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE
    0093-5208OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE
    0121-0671OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE
    0179-0187OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE
    0378-6605Oxybutynin Chlorideoxybutynin chloride
    0378-6610Oxybutynin Chlorideoxybutynin chloride
    0378-6615Oxybutynin Chlorideoxybutynin chloride
    0603-4975Oxybutynin Chlorideoxybutynin chloride
    0615-3512Oxybutynin ChlorideOxybutynin Chloride
    0615-7519Oxybutynin Chlorideoxybutynin chloride
    0615-7520Oxybutynin Chlorideoxybutynin chloride
    0615-7521oxybutynin chlorideoxybutynin chloride
    0615-8428Oxybutynin Chlorideoxybutynin chloride
    0832-0038Oxybutynin ChlorideOxybutynin Chloride
    0904-2821Oxybutynin ChlorideOxybutynin Chloride
    0904-6570Oxybutynin ChlorideOxybutynin Chloride
    0904-7027Oxybutynin ChlorideOxybutynin Chloride
    10135-609Oxybutynin ChlorideOxybutynin Chloride
    10135-610Oxybutynin ChlorideOxybutynin Chloride
    10135-611Oxybutynin ChlorideOxybutynin Chloride
    10135-640Oxybutynin ChlorideOxybutynin Chloride

    Trademark Results [GELNIQUE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GELNIQUE
    GELNIQUE
    87196781 5186582 Live/Registered
    Allergan Sales, LLC
    2016-10-07
    GELNIQUE
    GELNIQUE
    77660922 3700307 Dead/Cancelled
    ALLERGAN SALES, LLC
    2009-02-01
    GELNIQUE
    GELNIQUE
    77429789 3658979 Live/Registered
    ALLERGAN SALES, LLC
    2008-03-24

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.