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, USP, for intravenous use Initial U.S. Approval: 1991
Approved
Approval ID
fdb77e13-f5a7-4c4a-9f8e-338b702239c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2022
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 946499746
Products 3
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 Code0641-6196
Application NumberANDA074848
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROPOFOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 18, 2022
FDA Product Classification
INGREDIENTS (5)
EGG PHOSPHOLIPIDSInactive
Quantity: 12 mg in 1 mL
Code: 1Z74184RGV
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 1 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
GLYCERINInactive
Quantity: 22.5 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SOYBEAN OILInactive
Quantity: 100 mg in 1 mL
Code: 241ATL177A
Classification: IACT
PROPOFOLActive
Quantity: 10 mg in 1 mL
Code: YI7VU623SF
Classification: ACTIB
PROPOFOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6194
Application NumberANDA074848
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROPOFOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 18, 2022
FDA Product Classification
INGREDIENTS (5)
PROPOFOLActive
Quantity: 10 mg in 1 mL
Code: YI7VU623SF
Classification: ACTIB
GLYCERINInactive
Quantity: 22.5 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 1 mg in 1 mL
Code: LKG8494WBH
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
PROPOFOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6195
Application NumberANDA074848
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROPOFOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 18, 2022
FDA Product Classification
INGREDIENTS (5)
PROPOFOLActive
Quantity: 10 mg in 1 mL
Code: YI7VU623SF
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 1 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
GLYCERINInactive
Quantity: 22.5 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SOYBEAN OILInactive
Quantity: 100 mg in 1 mL
Code: 241ATL177A
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Quantity: 12 mg in 1 mL
Code: 1Z74184RGV
Classification: IACT