Propofol
Propofol Injectable Emulsion, USPRx only
Approved
Approval ID
475de1f2-9b88-455a-ba3c-48e96083c056
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-4569
Application NumberANDA205307
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propofol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 29, 2020
FDA Product Classification
INGREDIENTS (6)
PROPOFOLActive
Quantity: 10 mg in 1 mL
Code: YI7VU623SF
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
GLYCERINInactive
Quantity: 22.5 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Quantity: 12 mg in 1 mL
Code: 1Z74184RGV
Classification: IACT
SOYBEAN OILInactive
Quantity: 100 mg in 1 mL
Code: 241ATL177A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT