Search by Drug Name or NDC

    NDC 43063-0494-14 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 PD-Rx Pharmaceuticals, Inc.. The primary component is CYCLOBENZAPRINE HYDROCHLORIDE.

    Product Information

    NDC 43063-0494
    Product ID 43063-494_fcffc0f7-77a5-e410-e053-6294a90abb5a
    Associated GPIs 75100050100303
    GCN Sequence Number 047478
    GCN Sequence Number Description cyclobenzaprine HCl TABLET 5 MG ORAL
    HIC3 H6H
    HIC3 Description SKELETAL MUSCLE RELAXANTS
    GCN 12805
    HICL Sequence Number 001950
    HICL Sequence Number Description CYCLOBENZAPRINE HCL
    Brand/Generic Generic
    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 PD-Rx Pharmaceuticals, Inc.
    Pharmaceutical Class Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078048
    Listing Certified Through 2024-12-31

    Package

    NDC 43063-0494-14 (43063049414)

    NDC Package Code 43063-494-14
    Billing NDC 43063049414
    Package 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-14)
    Marketing Start Date 2014-07-31
    NDC Exclude Flag N
    Pricing Information N/A