Label: ACETYLCYSTEINE injection, solution

  • NDC Code(s): 70771-1412-1, 70771-1412-8
  • 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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  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – Vial Label

    NDC 70771-1412-1

    Acetylcysteine Injection

    6 g/30 mL

    (200 mg/mL)

    MUST BE FURTHER DILUTED

    PRIOR TO INTRAVENOUS USE

    30 mL Sterile

    Rx only

    vial label
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – Carton Label

    NDC 70771-1412-8

    Acetylcysteine Injection

    6 g/30 mL

    (200 mg/mL)

    MUST BE FURTHER DILUTED

    PRIOR TO INTRAVENOUS USE

    4 X 30 mL Sterile Vials

    Rx only

    carton
  • INGREDIENTS AND APPEARANCE
    ACETYLCYSTEINE 
    acetylcysteine injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1412
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC) ACETYLCYSTEINE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    NITROGEN (UNII: N762921K75)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1412-84 in 1 CARTON01/17/2019
    1NDC:70771-1412-130 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20816601/17/2019
    Labeler - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1412) , MANUFACTURE(70771-1412)