NDC 0603-7818

Nystatin

Nystatin

Nystatin is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical. The primary component is Nystatin.

Product ID0603-7818_5bf9ac3e-48ed-4e56-ad74-4e6a1358e0e4
NDC0603-7818
Product TypeHuman Prescription Drug
Proprietary NameNystatin
Generic NameNystatin
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2006-05-31
Marketing End Date2021-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA065315
Labeler NamePar Pharmaceutical
Substance NameNYSTATIN
Active Ingredient Strength100000 [USP'U]/g
Pharm ClassesPolyene Antifungal [EPC],Polyenes [CS]
NDC Exclude FlagN

Packaging

NDC 0603-7818-74

1 TUBE in 1 CARTON (0603-7818-74) > 15 g in 1 TUBE
Marketing Start Date2006-05-31
Marketing End Date2021-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-7818-74 [00603781874]

Nystatin CREAM
Marketing CategoryANDA
Application NumberANDA065315
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2006-05-31
Marketing End Date2021-07-31

NDC 0603-7818-78 [00603781878]

Nystatin CREAM
Marketing CategoryANDA
Application NumberANDA065315
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2006-05-31
Marketing End Date2021-07-31

NDC 0603-7818-88 [00603781888]

Nystatin CREAM
Marketing CategoryANDA
Application NumberANDA065315
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-05-31
Marketing End Date2021-07-31

Drug Details

Active Ingredients

IngredientStrength
NYSTATIN100000 [USP'U]/g

OpenFDA Data

SPL SET ID:fc141ac5-c14e-4abf-8f2f-98b50a0c63a4
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"

    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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