NDC 68382-370

NYSTATIN

Nystatin

NYSTATIN is a Topical Powder in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Nystatin.

Product ID68382-370_3cb6ca8c-20a3-4278-8d44-9154c86e2e5f
NDC68382-370
Product TypeHuman Prescription Drug
Proprietary NameNYSTATIN
Generic NameNystatin
Dosage FormPowder
Route of AdministrationTOPICAL
Marketing Start Date2021-10-06
Marketing CategoryANDA / ANDA
Application NumberANDA208581
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameNYSTATIN
Active Ingredient Strength100000 [USP'U]/g
Pharm ClassesPolyene Antifungal [EPC],Polyenes [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68382-370-01

15 g in 1 BOTTLE, PLASTIC (68382-370-01)
Marketing Start Date2021-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-370-01 [68382037001]

Nystatin POWDER
Marketing CategoryANDA
Application NumberANDA208581
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-08

NDC 68382-370-03 [68382037003]

Nystatin POWDER
Marketing CategoryANDA
Application NumberANDA208581
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-08

NDC 68382-370-02 [68382037002]

Nystatin POWDER
Marketing CategoryANDA
Application NumberANDA208581
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-08

Drug Details

Active Ingredients

IngredientStrength
NYSTATIN100000 [USP'U]/g

OpenFDA Data

SPL SET ID:2daf159d-6a12-4b5d-97b3-8069c17e7635
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 646456
  • Pharmacological Class

    • Polyene Antifungal [EPC]
    • Polyenes [CS]

    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
    13668-534NystatinNystatin
    13668-595NystatinNystatin
    16714-769NystatinNystatin
    17856-0037NystatinNystatin
    17856-0538NystatinNystatin
    17856-0811NystatinNYSTATIN
    21695-643NystatinNystatin
    21695-761NystatinNystatin
    23155-051NystatinNystatin
    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
    33261-896NystatinNystatin
    39822-3015NystatinNystatin
    42254-284NystatinNystatin
    42254-303NystatinNystatin

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