Search by Drug Name or NDC

    NDC 43386-0530-05 Nystatin 100000 U/g Details

    Nystatin 100000 U/g

    Nystatin is a TOPICAL POWDER in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals,Inc.. The primary component is NYSTATIN.

    Product Information

    NDC 43386-0530
    Product ID 43386-530_b0de02c7-980a-4947-ae03-f5ef52a4b06f
    Associated GPIs 90150080002920
    GCN Sequence Number 007284
    GCN Sequence Number Description nystatin POWDER 100000/G TOPICAL
    HIC3 Q5F
    HIC3 Description TOPICAL ANTIFUNGALS
    GCN 30160
    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 POWDER
    Route TOPICAL
    Active Ingredient Strength 100000
    Active Ingredient Units U/g
    Substance Name NYSTATIN
    Labeler Name Lupin Pharmaceuticals,Inc.
    Pharmaceutical Class Polyene Antifungal [EPC], Polyenes [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA065138
    Listing Certified Through 2024-12-31

    Package

    NDC 43386-0530-05 (43386053005)

    NDC Package Code 43386-530-05
    Billing NDC 43386053005
    Package 56.7 g in 1 BOTTLE, PLASTIC (43386-530-05)
    Marketing Start Date 2014-09-26
    NDC Exclude Flag N
    Pricing Information N/A