Label: METHOCARBAMOL- methocarbamol injection injection

  • NDC Code(s): 49396-0711-1
  • Packager: Renaissance Lakewood LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 19, 2018

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  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY

    The mechanism of action of methocarbamol in humans has not been established, but may be due to general CNS depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

  • Methocarbamol Injection USP

    metho package image

  • INGREDIENTS AND APPEARANCE
    METHOCARBAMOL 
    methocarbamol injection injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49396-0711
    Route of AdministrationPARENTERAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X) METHOCARBAMOL100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49396-0711-125 in 1 CARTON03/10/2017
    110 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20811603/10/2017
    Labeler - Renaissance Lakewood LLC (077744035)
    Registrant - Renaissance Lakewood LLC (077744035)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renaissance Lakewood LLC077744035manufacture(49396-0711) , analysis(49396-0711)