PROPOFOL 1%- propofol 1% injection, emulsion
Genixus

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.

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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.

Propofol 1% 100mg/10ml

Propofol 1% 200mg/20ml

PROPOFOL 1%
propofol 1% injection, emulsion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:80700-113(NDC:43598-549)
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PROPOFOL (UNII: YI7VU623SF) (PROPOFOL - UNII:YI7VU623SF)	PROPOFOL	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80700-113-11	10 in 1 BAG	03/29/2023
1	NDC:80700-113-10	10 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC:80700-113-12	25 in 1 BAG	03/29/2023
2	NDC:80700-113-10	10 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC:80700-113-21	10 in 1 BAG	03/29/2023
3	NDC:80700-113-20	20 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4	NDC:80700-113-22	25 in 1 BAG	03/29/2023
4	NDC:80700-113-20	20 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/29/2023

Labeler - Genixus (117436254)

Name	Address	ID/FEI	Business Operations
Establishment
Genixus		117436254	repack(80700-113) , analysis(80700-113)