Label: MYCOPHENOLATE MOFETIL injection, powder, lyophilized, for solution

  • NDC Code(s): 70771-1084-8
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 12, 2020

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  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – MYCOPHENOLATE MOFETIL 500 MG CONTAINER LABEL

    NDC 70771-1084-1

    Mycophenolate Mofetil for Injection, USP

    (500 mg per Vial)

    FOR INTRAVENOUS INFUSION ONLY

    PHARMACIST: Dispense the Medication Guide provided separately to each patient.

    SINGLE DOSE VIAL

    Rx only

    Zydus Pharmaceuticals

    Container Label

    PRINCIPAL DISPLAY PANEL - MYCOPHENOLATE MOFETIL 500 MG CARTON LABEL

    NDC 70771-1084-8

    Mycophenolate Mofetil for Injection, USP

    (500 mg per Vial)

    PHARMACIST: Dispense the Medication Guide provided separately to each patient.

    FOR INTRAVENOUS INFUSION ONLY

    SINGLE DOSE VIAL

    4 Vials

    Rx only

    Zydus Pharmaceuticals

    Carton Label
  • INGREDIENTS AND APPEARANCE
    MYCOPHENOLATE MOFETIL 
    mycophenolate mofetil injection, powder, lyophilized, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1084
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T) MYCOPHENOLATE MOFETIL500 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1084-84 in 1 CARTON09/22/2017
    120 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20447309/22/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1084) , MANUFACTURE(70771-1084)