NDC 0378-6615

Oxybutynin Chloride

Oxybutynin Chloride

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

Product ID0378-6615_63643284-5470-4c92-a119-ef135999ff85
NDC0378-6615
Product TypeHuman Prescription Drug
Proprietary NameOxybutynin Chloride
Generic NameOxybutynin Chloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-12-03
Marketing CategoryANDA / ANDA
Application NumberANDA076644
Labeler NameMylan Pharmaceuticals Inc.
Substance NameOXYBUTYNIN CHLORIDE
Active Ingredient Strength15 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-6615-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6615-01)
Marketing Start Date2015-12-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-6615-01 [00378661501]

Oxybutynin Chloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076644
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-03
Marketing End Date2020-01-31

NDC 0378-6615-05 [00378661505]

Oxybutynin Chloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076644
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-03
Marketing End Date2016-10-03

Drug Details

Active Ingredients

IngredientStrength
OXYBUTYNIN CHLORIDE15 mg/1

OpenFDA Data

SPL SET ID:46dab1c0-bbde-922c-39d7-6be818b49d12
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 863628
  • 863636
  • 863619
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68071-1875Oxybutynin ChlorideOxybutynin Chloride
    68071-1959Oxybutynin ChlorideOxybutynin Chloride
    68071-4395OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE
    68084-400Oxybutynin ChlorideOxybutynin Chloride
    68151-3646OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE
    68151-9200Oxybutynin ChlorideOxybutynin Chloride
    68788-6402Oxybutynin ChlorideOxybutynin Chloride
    68788-7109oxybutynin chlorideoxybutynin chloride
    68788-7234OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE
    69189-6605Oxybutynin ChlorideOxybutynin Chloride
    70404-006Oxybutynin ChlorideOxybutynin Chloride
    70518-0158oxybutynin chlorideoxybutynin chloride
    70518-0202Oxybutynin ChlorideOxybutynin Chloride
    70518-0965Oxybutynin ChlorideOxybutynin Chloride
    70518-1052Oxybutynin ChlorideOxybutynin Chloride
    70518-0856Oxybutynin ChlorideOxybutynin Chloride
    70518-1030Oxybutynin ChlorideOxybutynin Chloride
    70518-1205Oxybutynin ChlorideOxybutynin Chloride
    70518-1294OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE
    70518-1067Oxybutynin ChlorideOxybutynin Chloride
    70518-1941Oxybutynin ChlorideOxybutynin Chloride
    70954-005Oxybutynin ChlorideOxybutynin Chloride
    71335-0519Oxybutynin ChlorideOxybutynin Chloride
    71335-1014OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE
    71335-0610oxybutynin chlorideoxybutynin chloride
    10147-0761Oxybutynin ChlorideOxybutynin Chloride
    10147-0771Oxybutynin ChlorideOxybutynin Chloride
    10702-201Oxybutynin ChlorideOxybutynin Chloride

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