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    NDC 72887-0144-06 Ursodiol 400 mg 400 mg/1 Details

    Ursodiol 400 mg 400 mg/1

    Ursodiol 400 mg is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by FH2 Pharma LLC. The primary component is URSODIOL.

    Product Information

    NDC 72887-0144
    Product ID 72887-144_c28d41e2-14c2-4401-87ab-49b32239caba
    Associated GPIs 52100040000130
    GCN Sequence Number 081873
    GCN Sequence Number Description ursodiol CAPSULE 400 MG ORAL
    HIC3 D7A
    HIC3 Description BILE SALTS
    GCN 49115
    HICL Sequence Number 001370
    HICL Sequence Number Description URSODIOL
    Brand/Generic Generic
    Proprietary Name Ursodiol 400 mg
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ursodiol
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 400
    Active Ingredient Units mg/1
    Substance Name URSODIOL
    Labeler Name FH2 Pharma LLC
    Pharmaceutical Class Bile Acid [EPC], Bile Acids and Salts [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA205789
    Listing Certified Through 2024-12-31

    Package

    NDC 72887-0144-06 (72887014406)

    NDC Package Code 72887-144-06
    Billing NDC 72887014406
    Package 60 CAPSULE in 1 BOTTLE (72887-144-06)
    Marketing Start Date 2021-11-18
    NDC Exclude Flag N
    Pricing Information N/A