Label: DIHYDROERGOTAMINE MESYLATE injection

  • NDC Code(s): 62778-336-21, 62778-336-22
  • Packager: Hikma Farmaceutica
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 17, 2023

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  • ADVERSE REACTIONS

    To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

     

  • PRINCIPAL DISPLAY PANEL

    NDC 0143-9151-01   Rx only
    Dihydroergotamine
    Mesylate Injection, USP
    1 mg/mL
    For IV, IM or SC Use ONLY
    1 mL Single-Dose Vial

    vial label

    NDC 0143-9151-10   Rx only

    Dihydroergotamine
    Mesylate Injection, USP
    1 mg/mL
    For Intramuscular, Intravenous or Subcutaneous Use ONLY
    10 x 1 mL Single-Dose Vials

    Carton
  • INGREDIENTS AND APPEARANCE
    DIHYDROERGOTAMINE MESYLATE 
    dihydroergotamine mesylate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62778-336
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIHYDROERGOTAMINE MESYLATE (UNII: 81AXN7R2QT) (DIHYDROERGOTAMINE - UNII:436O5HM03C) DIHYDROERGOTAMINE MESYLATE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHANESULFONIC ACID (UNII: 12EH9M7279)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62778-336-2210 in 1 CARTON03/31/2023
    1NDC:62778-336-211 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04045303/31/2023
    Labeler - Hikma Farmaceutica (452742943)
    Registrant - Hikma Pharmaceuticals USA Inc. (946499746)
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