NDC Code(s) : 63323-270-26
Packager : Fresenius Kabi USA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PropofolPROPOFOL INJECTION, EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-270
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPOFOL(UNII: YI7VU623SF)
(PROPOFOL - UNII:YI7VU623SF) 		PROPOFOL10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL(UNII: 241ATL177A)100 mg in 1 mL
GLYCERIN(UNII: PDC6A3C0OX)22.5 mg in 1 mL
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)12 mg in 1 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-270-2610 in 1 BOX
120 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019627 10/07/2009

PRINCIPAL DISPLAY PANEL

P ACKAGE LABEL - PRINCIPAL DISPLAY - Propofol 20 mL Vial Label

NDC 63323-270-26

NP270125

PROPOFOL INJECTABLE EMULSION, USP

1% (10 mg/mL)

Contains EDTA

For IV Administration

SHAKE WELL BEFORE USING

20 mL Vial

Rx Only

 

np270125-vial
 


 


P ACKAGE LABEL - PRINCIPAL DISPLAY - Propofol 20 mL Vial Carton Label

NDC 63323-270-26

NP270125

PROPOFOL INJECTABLE EMULSION, USP

1% (10 mg/mL)

Contains EDTA

For IV Administration

SHAKE WELL BEFORE USING

For Single Patient Use Only

Rx only

Ten 20 mL Single-Patient Use Vials

 

np270125-vial