NDC 0316-0221

Nystatin Cream

Nystatin Cream

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

Product ID0316-0221_5b6da858-1ec5-5b34-e053-2991aa0abad5
NDC0316-0221
Product TypeHuman Prescription Drug
Proprietary NameNystatin Cream
Generic NameNystatin Cream
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2017-10-10
Marketing CategoryANDA / ANDA
Application NumberANDA207733
Labeler NameCrown Laboratories
Substance NameNYSTATIN
Active Ingredient Strength100000 [USP'U]/g
Pharm ClassesPolyene Antifungal [EPC],Polyenes [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0316-0221-15

1 TUBE in 1 CARTON (0316-0221-15) > 15 g in 1 TUBE
Marketing Start Date2017-10-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0316-0221-15 [00316022115]

Nystatin Cream CREAM
Marketing CategoryANDA
Application NumberANDA207733
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-10-10

NDC 0316-0221-30 [00316022130]

Nystatin Cream CREAM
Marketing CategoryANDA
Application NumberANDA207733
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-10-10

Drug Details

Active Ingredients

IngredientStrength
NYSTATIN100000 [USP'U]/g

OpenFDA Data

SPL SET ID:5a2b6fee-1437-0c3a-e053-2991aa0a3443
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 543546
  • UPC Code
  • 0303160221156
  • Pharmacological Class

    • Polyene Antifungal [EPC]
    • Polyenes [CS]

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

    NDCBrand NameGeneric Name
    0316-0221Nystatin CreamNystatin Cream
    0713-0678NystatinNystatin Cream
    68071-2483NystatinNystatin Cream
    68071-2658NystatinNystatin Cream
    68788-7513NystatinNystatin Cream
    68788-8234NystatinNystatin Cream
    71205-723NystatinNystatin Cream

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