Label: ZANOSAR- streptozocin powder, for solution

  • NDC Code(s): 68118-100-01
  • Packager: ESTEVE PHARMACEUTICALS, S.A.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 3, 2023

If you are a consumer or patient please visit this version.

  • HEALTH CARE PROVIDER LETTER

    Dear Health Care Provider Letter

    D-1

    D-2

    D-3

    D-4

  • HOW SUPPLIED

    How supplied

    NDC 68118-100-01: Each vial contains 1g Streptozocin Powder for concentrate for solution for infusion. Each carton contains 1 vial.

  • PRINCIPAL DISPLAY PANEL

    Vial Label Vial Label

  • PRINCIPAL DISPLAY PANEL

    Carton Label Carton Label

  • INGREDIENTS AND APPEARANCE
    ZANOSAR 
    streptozocin powder, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68118-100
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STREPTOZOCIN (UNII: 5W494URQ81) (STREPTOZOCIN - UNII:5W494URQ81) STREPTOZOCIN1 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68118-100-011 in 1 CARTON02/01/2023
    110 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage02/01/2023
    Labeler - ESTEVE PHARMACEUTICALS, S.A. (460023922)