NDC 21695-459

Oxistat

Oxiconazole Nitrate

Oxistat is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp.. The primary component is Oxiconazole Nitrate.

Product ID21695-459_0b5b9f06-15fc-432d-a891-8d91bf80f2d4
NDC21695-459
Product TypeHuman Prescription Drug
Proprietary NameOxistat
Generic NameOxiconazole Nitrate
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2006-01-25
Marketing CategoryNDA / NDA
Application NumberNDA020209
Labeler NameRebel Distributors Corp.
Substance NameOXICONAZOLE NITRATE
Active Ingredient Strength30 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-459-30

30 g in 1 TUBE (21695-459-30)
Marketing Start Date2006-01-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-459-30 [21695045930]

Oxistat LOTION
Marketing CategoryNDA
Application NumberNDA020209
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-01-25
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
OXICONAZOLE NITRATE30 mg/g

OpenFDA Data

SPL SET ID:094d5b1e-ccf6-4384-b208-fd70360ffda2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312140
  • 207249
  • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]

    NDC Crossover Matching brand name "Oxistat" or generic name "Oxiconazole Nitrate"

    NDCBrand NameGeneric Name
    10337-358Oxistatoxiconazole nitrate
    10337-359Oxistatoxiconazole nitrate
    21695-459Oxistatoxiconazole nitrate
    62559-285Oxistatoxiconazole nitrate
    0168-0358Oxiconazole NitrateOxiconazole Nitrate
    51672-1359Oxiconazole NitrateOxiconazole Nitrate

    Trademark Results [Oxistat]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OXISTAT
    OXISTAT
    73639623 1508836 Live/Registered
    GLAXO GROUP LIMITED
    1987-01-13
    OXISTAT
    OXISTAT
    73634588 1476608 Dead/Cancelled
    ZELLWEGER USTER AG
    1986-12-10

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