NDC 0574-2008

Nystop

Nystatin

Nystop is a Topical Powder in the Human Prescription Drug category. It is labeled and distributed by Padagis Us Llc. The primary component is Nystatin.

Product ID0574-2008_3209230e-c96d-44ce-9758-ec1ecdcda8de
NDC0574-2008
Product TypeHuman Prescription Drug
Proprietary NameNystop
Generic NameNystatin
Dosage FormPowder
Route of AdministrationTOPICAL
Marketing Start Date1996-08-16
Marketing CategoryANDA / ANDA
Application NumberANDA064118
Labeler NamePadagis US LLC
Substance NameNYSTATIN
Active Ingredient Strength100000 [USP'U]/g
Pharm ClassesPolyene Antifungal [EPC],Polyenes [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0574-2008-02

60 g in 1 BOTTLE, PLASTIC (0574-2008-02)
Marketing Start Date1996-08-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0574-2008-30 [00574200830]

Nystop POWDER
Marketing CategoryANDA
Application NumberANDA064118
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1996-08-16

NDC 0574-2008-02 [00574200802]

Nystop POWDER
Marketing CategoryANDA
Application NumberANDA064118
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1996-08-16

NDC 0574-2008-15 [00574200815]

Nystop POWDER
Marketing CategoryANDA
Application NumberANDA064118
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1996-08-16

Drug Details

Active Ingredients

IngredientStrength
NYSTATIN100000 [USP'U]/g

OpenFDA Data

SPL SET ID:e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 261178
  • 646456

    • Pharmacological Class

    • Polyene Antifungal [EPC]
    • Polyenes [CS]
    • Polyene Antifungal [EPC]
    • Polyenes [CS]

    NDC Crossover Matching brand name "Nystop" or generic name "Nystatin"

    NDCBrand NameGeneric Name
    0574-2008NystopNystatin
    0832-0465NyamycNystatin
    0093-0983NystatinNystatin
    0121-0810NystatinNYSTATIN
    0121-0868NystatinNYSTATIN
    0121-4785NystatinNystatin
    0121-4810NystatinNYSTATIN
    0168-0007Nystatinnystatin
    0168-0037nystatinnystatin
    0168-0054nystatinnystatin
    0472-0163NystatinNystatin
    0472-0166NystatinNystatin
    0603-1481NystatinNystatin
    0603-7818Nystatinnystatin
    0904-6456NystatinNystatin
    0904-7276NystatinNYSTATIN
    13668-534NystatinNystatin
    13668-595NystatinNystatin
    16714-769NystatinNystatin
    17856-0037NystatinNystatin
    17856-0538NystatinNystatin
    17856-0811NystatinNYSTATIN
    21695-643NystatinNystatin
    21695-761NystatinNystatin

    Trademark Results [Nystop]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NYSTOP
    NYSTOP
    75377918 2202936 Live/Registered
    PADDOCK LABORATORIES, LLC
    1997-10-23
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