Search by Drug Name or NDC

    NDC 76420-0205-10 tramadol hydrochloride 50 mg/1 Details

    tramadol hydrochloride 50 mg/1

    tramadol hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Asclemed USA, Inc.. The primary component is TRAMADOL HYDROCHLORIDE.

    Product Information

    NDC 76420-0205
    Product ID 76420-205_f9440001-dea9-2d5c-e053-6394a90aeb4d
    Associated GPIs 65100095100320
    GCN Sequence Number 023139
    GCN Sequence Number Description tramadol HCl TABLET 50 MG ORAL
    HIC3 H3A
    HIC3 Description OPIOID ANALGESICS
    GCN 07221
    HICL Sequence Number 008317
    HICL Sequence Number Description TRAMADOL HCL
    Brand/Generic Generic
    Proprietary Name tramadol hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name tramadol hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 50
    Active Ingredient Units mg/1
    Substance Name TRAMADOL HYDROCHLORIDE
    Labeler Name Asclemed USA, Inc.
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CIV
    Marketing Category ANDA
    Application Number ANDA075964
    Listing Certified Through 2024-12-31

    Package

    NDC 76420-0205-10 (76420020510)

    NDC Package Code 76420-205-10
    Billing NDC 76420020510
    Package 100 TABLET in 1 BOTTLE (76420-205-10)
    Marketing Start Date 2022-04-18
    NDC Exclude Flag N
    Pricing Information N/A