Propofol Injectable Emulsion
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
800646b8-83a8-01d9-3dc8-bb2ddcb8570c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2022
Manufacturers
FDA
Dr. Reddy's Laboratories, Inc.
DUNS: 802315887
Products 3
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 Code43598-549
Application NumberANDA205067
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propofol Injectable Emulsion
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 30, 2022
FDA Product Classification
INGREDIENTS (6)
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
propofolActive
Quantity: 10 mg in 1 mL
Code: YI7VU623SF
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Propofol Injectable Emulsion
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-548
Application NumberANDA205067
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propofol Injectable Emulsion
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 30, 2022
FDA Product Classification
INGREDIENTS (6)
propofolActive
Quantity: 10 mg in 1 mL
Code: YI7VU623SF
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
Propofol Injectable Emulsion
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-265
Application NumberANDA205067
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propofol Injectable Emulsion
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 30, 2022
FDA Product Classification
INGREDIENTS (6)
propofolActive
Quantity: 10 mg in 1 mL
Code: YI7VU623SF
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT