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    NDC 62135-0430-60 Ursodiol 300 mg/1 Details

    Ursodiol 300 mg/1

    Ursodiol is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Chartwell RX, LLC. The primary component is URSODIOL.

    Product Information

    NDC 62135-0430
    Product ID 62135-430_06fd3682-9361-c825-e063-6394a90a4cb3
    Associated GPIs
    GCN Sequence Number 003095
    GCN Sequence Number Description ursodiol CAPSULE 300 MG ORAL
    HIC3 D7A
    HIC3 Description BILE SALTS
    GCN 01070
    HICL Sequence Number 001370
    HICL Sequence Number Description URSODIOL
    Brand/Generic Generic
    Proprietary Name Ursodiol
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ursodiol
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 300
    Active Ingredient Units mg/1
    Substance Name URSODIOL
    Labeler Name Chartwell RX, LLC
    Pharmaceutical Class Bile Acid [EPC], Bile Acids and Salts [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA213555
    Listing Certified Through 2024-12-31

    Package

    NDC 62135-0430-60 (62135043060)

    NDC Package Code 62135-430-60
    Billing NDC 62135043060
    Package 60 CAPSULE in 1 BOTTLE (62135-430-60)
    Marketing Start Date 2023-01-03
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.53282
    Pricing Unit EA
    Effective Date 2024-02-21
    NDC Description URSODIOL 300 MG CAPSULE
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1
    Classification for Rate Setting G
    As of Date 2024-02-21
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis