NDC 0121-4785

Nystatin

Nystatin

Nystatin is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Nystatin.

Product ID0121-4785_7f6f191e-0969-4d20-8189-e65fb74bad39
NDC0121-4785
Product TypeHuman Prescription Drug
Proprietary NameNystatin
Generic NameNystatin
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2009-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA062512
Labeler NamePharmaceutical Associates, Inc.
Substance NameNYSTATIN
Active Ingredient Strength100000 [USP'U]/mL
Pharm ClassesPolyene Antifungal [EPC],Polyenes [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0121-4785-05

4 TRAY in 1 CASE (0121-4785-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2009-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-4785-35 [00121478535]

Nystatin SUSPENSION
Marketing CategoryANDA
Application NumberANDA062512
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-12-12
Inactivation Date2020-01-31

NDC 0121-4785-05 [00121478505]

Nystatin SUSPENSION
Marketing CategoryANDA
Application NumberANDA062512
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-06-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NYSTATIN100000 [USP'U]/mL

OpenFDA Data

SPL SET ID:8e451863-6c53-4069-bc0f-71224356bfcb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312055
  • 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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