propofol
These highlights do not include all the information needed to use PROPOFOL INJECTABLE EMULSION safely and effectively. See full prescribing information for PROPOFOL INJECTABLE EMULSION. PROPOFOL injectable emulsion, for intravenous use Initial U.S. Approval: 1991
Approved
Approval ID
fa93f173-7858-4d88-860e-76ab97e65c2f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 3, 2023
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 080579617
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
propofol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25021-608
Application NumberANDA075102
Product Classification
M
Marketing Category
C73584
G
Generic Name
propofol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 3, 2023
FDA Product Classification
INGREDIENTS (6)
propofolActive
Quantity: 10 mg in 1 mL
Code: YI7VU623SF
Classification: ACTIB
soybean oilInactive
Code: 241ATL177A
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
egg phospholipidsInactive
Code: 1Z74184RGV
Classification: IACT
sodium metabisulfiteInactive
Code: 4VON5FNS3C
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT