DOXORUBICIN HYDROCHLORIDE- doxorubicin hydrochloride injectable, liposomal 
Cadila Healthcare Limited

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DOXOrubicin Hydrochloride Liposome Injection

SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 mg/10 mL Container Label

NDC 49315-008-03

DOXOrubicin Hydrochloride Liposome Injection

20 mg/10 mL

(2 mg/mL)

Cytotoxic Agent                           Must be diluted

LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL

FOR INTRAVENOUS INFUSION ONLY

10 mL Single-Dose Vial

Rx only

20 mg/10mL vial label

20 mg/10 mL Carton Label

NDC 49315-008-03

DOXOrubicin Hydrochloride Liposome Injection

20 mg/10 mL

(2 mg/mL)

Cytotoxic Agent                           Must be diluted

LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL

FOR INTRAVENOUS INFUSION ONLY

Sterile

Refrigerate at 2? to 8? (36? to 46?)

Do not freeze

10 mL Single-Dose Vial

Rx only

20 mg/10 mL carton label

50 mg/25 mL Container Label

NDC 49315-009-07

DOXOrubicin Hydrochloride Liposome Injection

50 mg/25 mL

(2 mg/mL)

Cytotoxic Agent                           Must be diluted

LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL

FOR INTRAVENOUS INFUSION ONLY

25 mL Single-Dose Vial

Rx only

50 mg/25mL vial label

50 mg/25 mL Carton Label

NDC 49315-009-07

DOXOrubicin Hydrochloride Liposome Injection

50 mg/25 mL

(2 mg/mL)

Cytotoxic Agent                           Must be diluted

LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL

FOR INTRAVENOUS INFUSION ONLY

Sterile

Refrigerate at 2? to 8? (36? to 46?)

Do not freeze

25 mL Single-Dose Vial

Rx only

50 mg/25 mL carton label
DOXORUBICIN HYDROCHLORIDE 
doxorubicin hydrochloride injectable, liposomal
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49315-008
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXORUBICIN HYDROCHLORIDE (UNII: 82F2G7BL4E) (DOXORUBICIN - UNII:80168379AG) DOXORUBICIN HYDROCHLORIDE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT (UNII: 3L6NN8ZZKU) 3.19 mg  in 1 mL
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) 9.58 mg  in 1 mL
CHOLESTEROL (UNII: 97C5T2UQ7J) 3.19 mg  in 1 mL
AMMONIUM SULFATE (UNII: SU46BAM238) 0.6 mg  in 1 mL
SUCROSE (UNII: C151H8M554)  
HISTIDINE (UNII: 4QD397987E)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49315-008-031 in 1 CARTON09/14/2020
110 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21229909/14/2020
DOXORUBICIN HYDROCHLORIDE 
doxorubicin hydrochloride injectable, liposomal
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49315-009
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXORUBICIN HYDROCHLORIDE (UNII: 82F2G7BL4E) (DOXORUBICIN - UNII:80168379AG) DOXORUBICIN HYDROCHLORIDE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT (UNII: 3L6NN8ZZKU) 3.19 mg  in 1 mL
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) 9.58 mg  in 1 mL
CHOLESTEROL (UNII: 97C5T2UQ7J) 3.19 mg  in 1 mL
AMMONIUM SULFATE (UNII: SU46BAM238) 0.6 mg  in 1 mL
SUCROSE (UNII: C151H8M554)  
HISTIDINE (UNII: 4QD397987E)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49315-009-071 in 1 CARTON09/14/2020
125 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21229909/14/2020
Labeler - Cadila Healthcare Limited (650348852)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited650348852ANALYSIS(49315-008, 49315-009) , MANUFACTURE(49315-008, 49315-009)

Revised: 9/2020
Document Id: ad13df03-7d20-4ea9-aaf2-0358a5e0ced3
Set id: bad467d4-7e27-4eda-b4d3-854460f0adab
Version: 1
Effective Time: 20200915
 
Cadila Healthcare Limited