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    NDC 68462-0433-90 colesevelam hydrochloride 625 mg/1 Details

    colesevelam hydrochloride 625 mg/1

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

    Product Information

    NDC 68462-0433
    Product ID 68462-433_836cbdcd-e2b0-468f-8aff-32ecd9760e78
    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 hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name colesevelam hydrochloride
    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 Glenmark Pharmaceuticals Inc., USA
    Pharmaceutical Class Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203480
    Listing Certified Through 2024-12-31

    Package

    NDC 68462-0433-90 (68462043390)

    NDC Package Code 68462-433-90
    Billing NDC 68462043390
    Package 90 TABLET, FILM COATED in 1 BOTTLE (68462-433-90)
    Marketing Start Date 2018-05-18
    NDC Exclude Flag N
    Pricing Information N/A