PROPOFOL 1% injection, emulsion

Propofol 1% by

Drug Labeling and Warnings

Propofol 1% by is a Prescription medication manufactured, distributed, or labeled by Genixus. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, 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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/29/2023

Labeler - Genixus (117436254)

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