NDC 17856-0538

Nystatin

Nystatin

Nystatin is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corp.. The primary component is Nystatin.

Product ID17856-0538_8a722d13-c10b-4cfd-b1cc-ae0cdb9e4236
NDC17856-0538
Product TypeHuman Prescription Drug
Proprietary NameNystatin
Generic NameNystatin
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date1995-04-15
Marketing CategoryANDA / ANDA
Application NumberANDA062512
Labeler NameATLANTIC BIOLOGICALS CORP.
Substance NameNYSTATIN
Active Ingredient Strength100000 [USP'U]/mL
Pharm ClassesPolyene Antifungal [EPC],Polyenes [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 17856-0538-7

2 mL in 1 SYRINGE (17856-0538-7)
Marketing Start Date2017-10-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0538-5 [17856053805]

Nystatin SUSPENSION
Marketing CategoryANDA
Application NumberANDA062512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-10
Inactivation Date2020-01-31

NDC 17856-0538-6 [17856053806]

Nystatin SUSPENSION
Marketing CategoryANDA
Application NumberANDA062512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-13
Inactivation Date2020-01-31

NDC 17856-0538-9 [17856053809]

Nystatin SUSPENSION
Marketing CategoryANDA
Application NumberANDA062512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-13
Inactivation Date2020-01-31

NDC 17856-0538-8 [17856053808]

Nystatin SUSPENSION
Marketing CategoryANDA
Application NumberANDA062512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-13
Inactivation Date2020-01-31

NDC 17856-0538-1 [17856053801]

Nystatin SUSPENSION
Marketing CategoryANDA
Application NumberANDA062512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-25
Inactivation Date2020-01-31

NDC 17856-0538-7 [17856053807]

Nystatin SUSPENSION
Marketing CategoryANDA
Application NumberANDA062512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-13
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NYSTATIN100000 [USP'U]/mL

OpenFDA Data

SPL SET ID:8d3531b9-13b4-471b-8315-9d05c80208f6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312055
  • UPC Code
  • 0012000003783
  • 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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