NDC 53489-400

Nystatin

Nystatin

Nystatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Nystatin.

Product ID53489-400_2628bf08-c7f5-4aef-8e14-bf987eca87ea
NDC53489-400
Product TypeHuman Prescription Drug
Proprietary NameNystatin
Generic NameNystatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1988-12-22
Marketing CategoryANDA / ANDA
Application NumberANDA062838
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameNYSTATIN
Active Ingredient Strength500000 [USP'U]/1
Pharm ClassesPolyene Antifungal [EPC],Polyenes [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53489-400-01

100 TABLET, FILM COATED in 1 BOTTLE (53489-400-01)
Marketing Start Date1988-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53489-400-03 [53489040003]

Nystatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA062838
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1988-12-22

NDC 53489-400-05 [53489040005]

Nystatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA062838
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1988-12-22

NDC 53489-400-02 [53489040002]

Nystatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA062838
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1988-12-22

NDC 53489-400-10 [53489040010]

Nystatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA062838
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1988-12-22

NDC 53489-400-01 [53489040001]

Nystatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA062838
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-12-22

Drug Details

Active Ingredients

IngredientStrength
NYSTATIN500000 [USP'U]/1

OpenFDA Data

SPL SET ID:b70731df-fead-4f40-941e-7889a9c5d800
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312059

    • Pharmacological Class

    • Polyene Antifungal [EPC]
    • Polyenes [CS]

    Medicade Reported Pricing

    53489040001 NYSTATIN 500,000 UNIT ORAL TAB

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0093-0983NystatinNystatin
    0121-0810NystatinNYSTATIN
    0121-0868NystatinNYSTATIN
    0121-4785NystatinNystatin
    0121-4810NystatinNYSTATIN
    0168-0007Nystatinnystatin
    0168-0037nystatinnystatin
    0168-0054nystatinnystatin
    0374-5160NystatinNystatin Ointment
    0472-0163NystatinNystatin
    0472-0166NystatinNystatin
    0603-1481NystatinNystatin
    0603-7818Nystatinnystatin
    0713-0678NystatinNystatin Cream
    0713-0686NystatinNystatin Ointment
    0904-6456NystatinNystatin
    0904-7276NystatinNYSTATIN
    13668-534NystatinNystatin
    13668-595NystatinNystatin
    68071-4293NystatinNystatin
    68151-1487NystatinNystatin
    68094-599NystatinNystatin
    68308-152NystatinNystatin
    68258-3046NystatinNystatin
    68382-333NystatinNystatin
    68382-370NystatinNystatin
    68788-0178NystatinNystatin
    68788-7366NystatinNystatin
    68788-6792NystatinNystatin
    68788-9516NystatinNystatin
    68788-9247nystatinnystatin
    68788-9072NystatinNystatin
    69315-306NYSTATINNYSTATIN
    70166-331NystatinNystatin
    70518-1305NystatinNystatin
    70771-1357NystatinNystatin
    71205-106NystatinNystatin
    76413-167NystatinNystatin
    76413-119nystatinnystatin
    76519-1007NystatinNystatin
    16714-769NystatinNystatin
    17856-0538NystatinNystatin
    17856-0037NystatinNystatin
    21695-643NystatinNystatin
    21695-761NystatinNystatin
    23155-051NystatinNystatin
    33261-896NystatinNystatin
    39822-3015NystatinNystatin
    42254-284NystatinNystatin
    42254-303NystatinNystatin
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