NDC 0713-0678

Nystatin

Nystatin Cream

Nystatin is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by G&w Laboratories, Inc.. The primary component is Nystatin.

Product ID0713-0678_5337115c-1f84-e2ea-863e-31458b8b53f9
NDC0713-0678
Product TypeHuman Prescription Drug
Proprietary NameNystatin
Generic NameNystatin Cream
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2015-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA061966
Labeler NameG&W Laboratories, Inc.
Substance NameNYSTATIN
Active Ingredient Strength100000 [USP'U]/g
Pharm ClassesPolyene Antifungal [EPC],Polyenes [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0713-0678-15

1 TUBE in 1 CARTON (0713-0678-15) > 15 g in 1 TUBE
Marketing Start Date2015-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0713-0678-31 [00713067831]

Nystatin CREAM
Marketing CategoryANDA
Application NumberANDA061966
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-04-01

NDC 0713-0678-15 [00713067815]

Nystatin CREAM
Marketing CategoryANDA
Application NumberANDA061966
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-04-01

Drug Details

Active Ingredients

IngredientStrength
NYSTATIN100000 [USP'U]/g

OpenFDA Data

SPL SET ID:ec1b52af-d38e-eba1-e63c-dba4341d3af2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 543546
  • Pharmacological Class

    • Polyene Antifungal [EPC]
    • Polyenes [CS]

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

    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

    © 2023 FDA.report
    This site is not affiliated with or endorsed by the FDA.