Label: PROPOFOL 1% injection, emulsion

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 December 27, 2023

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  • DESCRIPTION

    Propofol injectable emulsion, USP is a sterile, nonpyrogenic white or almost white, homogeneous
    emulsion, containing 10 mg/mL of propofol, USP suitable for intravenous administration. Propofol,
    USP is chemically described as 2,6-diisopropylphenol and has a molecular weight of 178.27.
    The structural formula is:

    propofol structure

    Propofol, USP is slightly soluble in water and, thus, is formulated in a white, oil-in-water emulsion.
    The pKa is 11. The octanol/water partition coefficient for propofol, USP is 6761:1 at a pH of 4.5 to
    7.4. In addition to the active component, propofol, USP the formulation also contains
    soybean oil (100 mg/mL), glycerol (22.5 mg/mL), egg phospholipids (12 mg/mL); and benzyl alcohol
    (0.15%); with sodium hydroxide to adjust pH. Propofol injectable emulsion, USP is isotonic and has
    a pH of 5.5 to 7.4.

  • PRINCIPAL DISPLAY PANEL

    Propofol 1% 100mg/10ml

    Propofol 1% 200mg/20ml

  • INGREDIENTS AND APPEARANCE
    PROPOFOL 1% 
    propofol 1% injection, emulsion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80700-113(NDC:43598-549)
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPOFOL (UNII: YI7VU623SF) (PROPOFOL - UNII:YI7VU623SF) PROPOFOL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 22.5 mg  in 1 mL
    SOYBEAN OIL (UNII: 241ATL177A) 100 mg  in 1 mL
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) 12 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.0015 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80700-113-1110 in 1 BAG03/29/2023
    1NDC:80700-113-1010 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:80700-113-1225 in 1 BAG03/29/2023
    2NDC:80700-113-1010 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:80700-113-2110 in 1 BAG03/29/2023
    3NDC:80700-113-2020 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    4NDC:80700-113-2225 in 1 BAG03/29/2023
    4NDC:80700-113-2020 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/29/2023
    Labeler - Genixus (117436254)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genixus117436254repack(80700-113) , analysis(80700-113)