Propofol Multidose
Propofol Multidose
Approved
Approval ID
635eb538-efae-41c5-9d8f-7c71197ac8ed
Product Type
PRESCRIPTION ANIMAL DRUG LABEL
Effective Date
May 1, 2025
Manufacturers
FDA
Covetrus North America
DUNS: 603750329
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
propofol injectable emulsion
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11695-7036
Application NumberANADA200793
Product Classification
M
Marketing Category
C73583
G
Generic Name
propofol injectable emulsion
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 1, 2025
FDA Product Classification
INGREDIENTS (9)
PROPOFOLActive
Quantity: 10 mg in 1 mL
Code: YI7VU623SF
Classification: ACTIB
SOYBEAN OILInactive
Quantity: 100 mg in 1 mL
Code: 241ATL177A
Classification: IACT
GLYCERINInactive
Quantity: 22.5 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 20 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
OLEIC ACIDInactive
Quantity: 0.6 mg in 1 mL
Code: 2UMI9U37CP
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Quantity: 12 mg in 1 mL
Code: 1Z74184RGV
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT