Label: NORFLEX- orphenadrine citrate tablet, extended release

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 4, 2020

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  • Dosage and Administration Section

    DOSAGE AND ADMINISTRATION

    Adults

    Two tablets per day; one in the morning and one in the evening.

  • Indications and Usage Section

    INDICATIONS AND USAGE

    Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

  • Principal Display Panel

    Orphenadrine Citrate 100mg

  • INGREDIENTS AND APPEARANCE
    NORFLEX 
    orphenadrine citrate tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0117(NDC:43386-480)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9) ORPHENADRINE CITRATE100 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code NL4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0117-130 in 1 BOTTLE; Type 0: Not a Combination Product06/19/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04028406/19/1998
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0117)