Search by Drug Name or NDC

    NDC 65649-0551-07 Relistor 12 mg/.6mL Details

    Relistor 12 mg/.6mL

    Relistor is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Salix Pharmaceuticals, Inc.. The primary component is METHYLNALTREXONE BROMIDE.

    Product Information

    NDC 65649-0551
    Product ID 65649-551_0c52697c-202f-6baa-e063-6294a90a2591
    Associated GPIs 52580050102020
    GCN Sequence Number 064011
    GCN Sequence Number Description methylnaltrexone bromide VIAL 12MG/0.6ML SUBCUT
    HIC3 H3Y
    HIC3 Description MU-OPIOID RECEPTOR ANTAGONISTS,PERIPHERALLY-ACTING
    GCN 99722
    HICL Sequence Number 035611
    HICL Sequence Number Description METHYLNALTREXONE BROMIDE
    Brand/Generic Brand
    Proprietary Name Relistor
    Proprietary Name Suffix n/a
    Non-Proprietary Name Methylnaltrexone bromide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route SUBCUTANEOUS
    Active Ingredient Strength 12
    Active Ingredient Units mg/.6mL
    Substance Name METHYLNALTREXONE BROMIDE
    Labeler Name Salix Pharmaceuticals, Inc.
    Pharmaceutical Class Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021964
    Listing Certified Through 2024-12-31

    Package

    NDC 65649-0551-07 (65649055107)

    NDC Package Code 65649-551-07
    Billing NDC 65649055107
    Package 1 BLISTER PACK in 1 CARTON (65649-551-07) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE
    Marketing Start Date 2008-04-24
    NDC Exclude Flag N
    Pricing Information N/A