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    NDC 53746-0540-10 CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Details

    CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1

    CYCLOBENZAPRINE HYDROCHLORIDE is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is CYCLOBENZAPRINE HYDROCHLORIDE.

    Product Information

    NDC 53746-0540
    Product ID 53746-540_b0e32570-da9f-4fa8-a0a2-0334fce7ff7a
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name CYCLOBENZAPRINE HYDROCHLORIDE
    Proprietary Name Suffix n/a
    Non-Proprietary Name CYCLOBENZAPRINE HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name CYCLOBENZAPRINE HYDROCHLORIDE
    Labeler Name Amneal Pharmaceuticals of New York LLC
    Pharmaceutical Class Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078218
    Listing Certified Through 2024-12-31

    Package

    NDC 53746-0540-10 (53746054010)

    NDC Package Code 53746-540-10
    Billing NDC 53746054010
    Package 1000 TABLET, FILM COATED in 1 BOTTLE (53746-540-10)
    Marketing Start Date 2010-02-18
    NDC Exclude Flag N
    Pricing Information N/A