NDC 53002-8220

Nystatin

Nystatin

Nystatin is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Nystatin.

Product ID53002-8220_55187fff-7448-40e7-bbc0-a665f0017ed0
NDC53002-8220
Product TypeHuman Prescription Drug
Proprietary NameNystatin
Generic NameNystatin
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2006-09-15
Marketing CategoryANDA / ANDA
Application NumberANDA062472
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameNYSTATIN
Active Ingredient Strength100000 [USP'U]/g
Pharm ClassesPolyene Antifungal [EPC],Polyenes [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53002-8220-1

15 g in 1 TUBE (53002-8220-1)
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-8220-1 [53002822001]

Nystatin OINTMENT
Marketing CategoryANDA
Application NumberANDA062472
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NYSTATIN100000 [USP'U]/g

OpenFDA Data

SPL SET ID:0ee89f89-e90d-4706-9fa5-a61b5fde4470
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 884308
  • 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
    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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