NDC 70518-1457

oxybutynin

Oxybutynin

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

Product ID70518-1457_7758b057-0313-1dea-e053-2991aa0a0d83
NDC70518-1457
Product TypeHuman Prescription Drug
Proprietary Nameoxybutynin
Generic NameOxybutynin
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-10-03
Marketing CategoryANDA / ANDA
Application NumberANDA202332
Labeler NameREMEDYREPACK 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 70518-1457-0

90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-1457-0)
Marketing Start Date2018-10-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1457-0 [70518145700]

oxybutynin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202332
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-03
Marketing End Date2020-05-21

Drug Details

Active Ingredients

IngredientStrength
OXYBUTYNIN CHLORIDE15 mg/1

OpenFDA Data

SPL SET ID:229d8756-c5de-4cf8-b455-4c6bd22a3c3c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 863628

    • Pharmacological Class

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

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