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    NDC 00536-1323-34 Dextromethorphan HBr 15 mg/1 Details

    Dextromethorphan HBr 15 mg/1

    Dextromethorphan HBr is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is DEXTROMETHORPHAN HYDROBROMIDE.

    Product Information

    NDC 00536-1323
    Product ID 0536-1323_ecba4eba-ffdb-4196-954c-c3bcaab51658
    Associated GPIs 43102030500110
    GCN Sequence Number 004622
    GCN Sequence Number Description dextromethorphan HBr CAPSULE 15 MG ORAL
    HIC3 H6C
    HIC3 Description ANTITUSSIVES, NON-OPIOID
    GCN 17770
    HICL Sequence Number 001925
    HICL Sequence Number Description DEXTROMETHORPHAN HBR
    Brand/Generic Generic
    Proprietary Name Dextromethorphan HBr
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dextromethorphan HBr
    Product Type HUMAN OTC DRUG
    Dosage Form CAPSULE, LIQUID FILLED
    Route ORAL
    Active Ingredient Strength 15
    Active Ingredient Units mg/1
    Substance Name DEXTROMETHORPHAN HYDROBROMIDE
    Labeler Name Rugby Laboratories
    Pharmaceutical Class Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part341
    Listing Certified Through 2023-12-31

    Package

    NDC 00536-1323-34 (00536132334)

    NDC Package Code 0536-1323-34
    Billing NDC 00536132334
    Package 1 BOTTLE, PLASTIC in 1 PACKAGE (0536-1323-34) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
    Marketing Start Date 2020-10-30
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 5eef145a-e05b-4e81-a3a1-c55c458fe639 Details

    Revised: 10/2022