NDC 68382-256

oxybutynin

Oxybutynin

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

Product ID68382-256_08f2f8b4-0532-471c-bcb8-d0023104e3f4
NDC68382-256
Product TypeHuman Prescription Drug
Proprietary Nameoxybutynin
Generic NameOxybutynin
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-08-10
Marketing CategoryANDA / ANDA
Application NumberANDA202332
Labeler NameZydus Pharmaceuticals USA Inc.
Substance NameOXYBUTYNIN CHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68382-256-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-256-01)
Marketing Start Date2017-08-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-256-14 [68382025614]

oxybutynin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202332
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-10

NDC 68382-256-30 [68382025630]

oxybutynin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202332
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-10

NDC 68382-256-06 [68382025606]

oxybutynin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202332
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-10

NDC 68382-256-05 [68382025605]

oxybutynin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202332
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-10

NDC 68382-256-77 [68382025677]

oxybutynin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202332
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-10

NDC 68382-256-16 [68382025616]

oxybutynin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202332
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-10

NDC 68382-256-01 [68382025601]

oxybutynin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202332
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-10

Drug Details

Active Ingredients

IngredientStrength
OXYBUTYNIN CHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:c042bf06-79a3-4dc7-ae05-3ef3cfae9d44
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 863628
  • 863636
  • 863619
    • UPC Code
  • 0368382255013

    • Pharmacological Class

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

    Medicade Reported Pricing

    68382025605 OXYBUTYNIN CL ER 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382025601 OXYBUTYNIN CL ER 10 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0615-8219oxybutyninoxybutynin
    0615-8220OxybutyninOxybutynin
    50090-5352oxybutyninoxybutynin
    50090-5353oxybutyninoxybutynin
    68382-255oxybutyninoxybutynin
    68382-256oxybutyninoxybutynin
    68382-257oxybutyninoxybutynin
    70518-1457oxybutyninoxybutynin
    70518-2331oxybutyninoxybutynin
    70771-1086oxybutyninoxybutynin
    70771-1087oxybutyninoxybutynin
    70771-1088oxybutyninoxybutynin
    71335-0974oxybutyninoxybutynin
    0023-6153OXYTROLOxybutynin
    52544-920OXYTROLOxybutynin
    0023-9637Oxytrol for WomenOxybutynin
    52544-166Oxytrol For Womenoxybutynin
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.