NDC 43353-285

Oxybutynin Chloride Extended Release

Oxybutynin Chloride

Oxybutynin Chloride Extended Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Oxybutynin Chloride.

Product ID43353-285_9eda2c93-de21-45ec-a9dc-1329d6d44be7
NDC43353-285
Product TypeHuman Prescription Drug
Proprietary NameOxybutynin Chloride Extended Release
Generic NameOxybutynin Chloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA078503
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameOXYBUTYNIN CHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-285-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-285-30)
Marketing Start Date2017-03-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-285-60 [43353028560]

Oxybutynin Chloride Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078503
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-02

NDC 43353-285-30 [43353028530]

Oxybutynin Chloride Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078503
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-02

NDC 43353-285-53 [43353028553]

Oxybutynin Chloride Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078503
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-02

Drug Details

Active Ingredients

IngredientStrength
OXYBUTYNIN CHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:e985e201-2fb3-4781-9790-a1a3db1ae2a1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 863636

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    68071-2013Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    68084-480Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    68084-610Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    70518-0705Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    71335-0669Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    42291-634Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    42291-633Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    42291-635Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    43353-285Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    43063-790Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    43353-284Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    43353-322Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    43353-282Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    50090-4192Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    50268-629Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    50268-627Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    50268-628Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    62175-271Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    62175-270Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    62175-272Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    63739-548Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    64980-209Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    64980-210Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    64980-211Oxybutynin Chloride Extended ReleaseOxybutynin Chloride Extended Release
    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.