Search by Drug Name or NDC

    NDC 50090-5315-00 Nystatin 100000 [USP'U]/mL Details

    Nystatin 100000 [USP'U]/mL

    Nystatin is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by A-S Medication Solutions. The primary component is NYSTATIN.

    Product Information

    NDC 50090-5315
    Product ID 50090-5315_7b3059b0-402b-4cea-88c4-5e7e787a34e7
    Associated GPIs
    GCN Sequence Number 009537
    GCN Sequence Number Description nystatin ORAL SUSP 100000/ML ORAL
    HIC3 W3A
    HIC3 Description ANTIFUNGAL ANTIBIOTICS
    GCN 42440
    HICL Sequence Number 004129
    HICL Sequence Number Description NYSTATIN
    Brand/Generic Generic
    Proprietary Name Nystatin
    Proprietary Name Suffix n/a
    Non-Proprietary Name NYSTATIN
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SUSPENSION
    Route ORAL
    Active Ingredient Strength 100000
    Active Ingredient Units [USP'U]/mL
    Substance Name NYSTATIN
    Labeler Name A-S Medication Solutions
    Pharmaceutical Class Polyene Antifungal [EPC], Polyenes [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203621
    Listing Certified Through 2024-12-31

    Package

    NDC 50090-5315-00 (50090531500)

    NDC Package Code 50090-5315-0
    Billing NDC 50090531500
    Package 60 mL in 1 BOTTLE, DROPPER (50090-5315-0)
    Marketing Start Date 2020-10-29
    NDC Exclude Flag N
    Pricing Information N/A