NDC 50458-805

Ditropan XL

Oxybutynin Chloride

Ditropan XL is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Oxybutynin Chloride.

Product ID50458-805_3208919a-639a-11ea-84ff-3a1efc2ca371
NDC50458-805
Product TypeHuman Prescription Drug
Proprietary NameDitropan XL
Generic NameOxybutynin Chloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date1999-06-26
Marketing CategoryNDA / NDA
Application NumberNDA020897
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameOXYBUTYNIN CHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50458-805-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-805-01)
Marketing Start Date1999-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-805-01 [50458080501]

Ditropan XL TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020897
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-06-26

Drug Details

Active Ingredients

IngredientStrength
OXYBUTYNIN CHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:36cc9115-bef3-48fa-93ff-bcda24cf26e2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 863638
  • 863622
  • 863636
  • 863619

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Ditropan XL" or generic name "Oxybutynin Chloride"

    NDCBrand NameGeneric Name
    50458-810Ditropan XLDitropan XL
    50458-805Ditropan XLDitropan XL
    0023-5812GELNIQUEoxybutynin chloride
    0023-5861GELNIQUEoxybutynin chloride
    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 [Ditropan]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DITROPAN
    DITROPAN
    75695647 2416993 Dead/Cancelled
    ALZA Corporation
    1999-04-30
    DITROPAN
    DITROPAN
    72399902 0964552 Dead/Cancelled
    MARION LABORATORIES, INC.
    1971-08-11
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