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    NDC 68382-0619-77 Colesevelam 625 mg/1 Details

    Colesevelam 625 mg/1

    Colesevelam is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is COLESEVELAM HYDROCHLORIDE.

    Product Information

    NDC 68382-0619
    Product ID 68382-619_bd5f9caf-784b-4565-a8b4-d330d3e93160
    Associated GPIs 39100016100330
    GCN Sequence Number 046172
    GCN Sequence Number Description colesevelam HCl TABLET 625 MG ORAL
    HIC3 D7L
    HIC3 Description BILE SALT SEQUESTRANTS
    GCN 16300
    HICL Sequence Number 021452
    HICL Sequence Number Description COLESEVELAM HCL
    Brand/Generic Generic
    Proprietary Name Colesevelam
    Proprietary Name Suffix n/a
    Non-Proprietary Name Colesevelam
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 625
    Active Ingredient Units mg/1
    Substance Name COLESEVELAM HYDROCHLORIDE
    Labeler Name Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207765
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0619-77 (68382061977)

    NDC Package Code 68382-619-77
    Billing NDC 68382061977
    Package 10 BLISTER PACK in 1 CARTON (68382-619-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-619-30)
    Marketing Start Date 2019-10-11
    NDC Exclude Flag N
    Pricing Information N/A