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    NDC 55513-0504-50 LUMAKRAS 320 mg/1 Details

    LUMAKRAS 320 mg/1

    LUMAKRAS is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amgen Inc. The primary component is SOTORASIB.

    Product Information

    NDC 55513-0504
    Product ID 55513-504_336c6783-a078-4639-ba70-b59fdc55ce43
    Associated GPIs
    GCN Sequence Number 084482
    GCN Sequence Number Description sotorasib TABLET 320 MG ORAL
    HIC3 V5A
    HIC3 Description ANTINEOPLASTIC - KRAS PROTEIN INHIBITOR
    GCN 53809
    HICL Sequence Number 047400
    HICL Sequence Number Description SOTORASIB
    Brand/Generic Brand
    Proprietary Name LUMAKRAS
    Proprietary Name Suffix n/a
    Non-Proprietary Name sotorasib
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, COATED
    Route ORAL
    Active Ingredient Strength 320
    Active Ingredient Units mg/1
    Substance Name SOTORASIB
    Labeler Name Amgen Inc
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA214665
    Listing Certified Through 2024-12-31

    Package

    NDC 55513-0504-50 (55513050450)

    NDC Package Code 55513-504-50
    Billing NDC 55513050450
    Package 1 BOTTLE, PLASTIC in 1 CARTON (55513-504-50) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC
    Marketing Start Date 2023-02-02
    NDC Exclude Flag N
    Pricing Information N/A