NDC Code(s) : 47335-082-50, 47335-083-50
Packager : Sun Pharma Global FZE

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LIPODOX Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-082
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXORUBICIN HYDROCHLORIDE(UNII: 82F2G7BL4E)
(DOXORUBICIN - UNII:80168379AG) 		DOXORUBICIN HYDROCHLORIDE2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT(UNII: 3L6NN8ZZKU)
CHOLESTEROL(UNII: 97C5T2UQ7J)
AMMONIUM SULFATE(UNII: SU46BAM238)
HISTIDINE(UNII: 4QD397987E)
SUCROSE(UNII: C151H8M554)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-082-501 in 1 PACKAGE
110 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug for use in drug shortage 02/09/2012
LIPODOX 50 Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-083
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXORUBICIN HYDROCHLORIDE(UNII: 82F2G7BL4E)
(DOXORUBICIN - UNII:80168379AG) 		DOXORUBICIN HYDROCHLORIDE2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT(UNII: 3L6NN8ZZKU)
CHOLESTEROL(UNII: 97C5T2UQ7J)
AMMONIUM SULFATE(UNII: SU46BAM238)
HISTIDINE(UNII: 4QD397987E)
SUCROSE(UNII: C151H8M554)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-083-501 in 1 PACKAGE
125 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug for use in drug shortage 02/09/2012

PRINCIPAL DISPLAY PANEL


NDC 47335-082-50
10 ml
Doxorubicin Hydrochloride Liposome Injection
LIPODOX
2 mg/ml
(Pegylated Liposomal)
Concentrate for Infusion
LIPOSOMAL FORMULATION
DO NOT SUBSTITUTE
 
carton-lipodox

PRINCIPAL DISPLAY PANEL


NDC 47335-083-50
25 ml
Doxorubicin Hydrochloride Liposome Injection
LIPODOX 50
2 mg/ml
(Pegylated Liposomal)
Concentrate for Infusion
LIPOSOMAL FORMULATION
DO NOT SUBSTITUTE
carton-lipodox-50