NDC 68382-333

Nystatin

Nystatin

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

Product ID68382-333_7473045c-95ce-4a4d-8902-adf0d8f5d4d1
NDC68382-333
Product TypeHuman Prescription Drug
Proprietary NameNystatin
Generic NameNystatin
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2018-08-08
Marketing CategoryANDA / ANDA
Application NumberANDA207767
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameNYSTATIN
Active Ingredient Strength100000 U/g
Pharm ClassesPolyene Antifungal [EPC],Polyenes [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68382-333-01

15 g in 1 TUBE (68382-333-01)
Marketing Start Date2018-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-333-01 [68382033301]

Nystatin OINTMENT
Marketing CategoryANDA
Application NumberANDA207767
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-08-08

NDC 68382-333-02 [68382033302]

Nystatin OINTMENT
Marketing CategoryANDA
Application NumberANDA207767
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-08-08

Drug Details

Active Ingredients

IngredientStrength
NYSTATIN100000 U/g

OpenFDA Data

SPL SET ID:cb4fbe7e-1ec8-4e40-bef0-ebcf28c01bce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 884308
  • UPC Code
  • 0368382333018
  • 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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