NDC Code(s) : 68001-492-36, 68001-493-26
Packager : BluePoint Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Doxorubicin HydrochlorideDoxorubicin Hydrochloride INJECTABLE, LIPOSOMAL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-492
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
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)9.58 mg in 1 mL
SODIUM N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE(UNII: 3L6NN8ZZKU)3.19 mg in 1 mL
CHOLESTEROL(UNII: 97C5T2UQ7J)3.19 mg in 1 mL
AMMONIUM SULFATE(UNII: SU46BAM238)0.6 mg in 1 mL
HISTIDINE(UNII: 4QD397987E)
SUCROSE(UNII: C151H8M554)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-492-361 in 1 PACKAGE 31/05/2021
110 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203263 05/31/2021
Doxorubicin HydrochlorideDoxorubicin Hydrochloride INJECTABLE, LIPOSOMAL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-493
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
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)9.58 mg in 1 mL
SODIUM N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE(UNII: 3L6NN8ZZKU)3.19 mg in 1 mL
CHOLESTEROL(UNII: 97C5T2UQ7J)3.19 mg in 1 mL
AMMONIUM SULFATE(UNII: SU46BAM238)0.6 mg in 1 mL
HISTIDINE(UNII: 4QD397987E)
SUCROSE(UNII: C151H8M554)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-493-261 in 1 PACKAGE 31/05/2021
125 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203263 05/31/2021

LABELER - BluePoint Laboratories(985523874)

Establishment
Name Address ID/FEI Business Operations
Sun Pharmaceutical Industries Limited 725959238 analysis(68001-492, 68001-493), manufacture(68001-492, 68001-493)

PRINCIPAL DISPLAY PANEL

NDC 68001-492-36
DOXOrubicin Hydrochloride Liposome Injection
20 mg/10 mL (2 mg/mL)
Cytotoxic Agent
Must be diluted
LIPOSOMAL FORMULATION
DO NOT SUBSTITUTE
FOR INTRAVENOUS INFUSION ONLY AFTER DILUTION
Store in a refrigerator, 2°C to 8°C (36°F to 46°F).
Do Not Freeze.

Vial Label 10ml

PRINCIPAL DISPLAY PANEL

NDC 68001-492-36
DOXOrubicin Hydrochloride Liposome Injection
20 mg/10 mL (2 mg/mL)
Sterile
Cytotoxic Agent
MUST BE DILUTED PRIOR TO ADMINISTRATION
LIPOSOMAL FORMULATION
DO NOT SUBSTITUTE
FOR INTRAVENOUS INFUSION ONLY AFTER DILUTION
Rx only
10 mL Single-dose Vial

Carton 10ml

PRINCIPAL DISPLAY PANEL

NDC 68001-493-26
DOXOrubicin Hydrochloride Liposome Injection
50 mg/25 mL (2 mg/mL)
Cytotoxic Agent
Must be diluted
LIPOSOMAL FORMULATION

DO NOT SUBSTITUTE
FOR INTRAVENOUS INFUSION ONLY AFTER DILUTION
Store in a refrigerator, 2°C to 8°C (36°F to 46°F).
Do Not Freeze.

Vial Label

PRINCIPAL DISPLAY PANEL

NDC 68001-493-26

DOXOrubicin Hydrochloride Liposome Injection

50 mg/25 mL (2 mg/mL)

Sterile

Cytotoxic Agent

MUST BE DILUTED PRIOR TO ADMINISTRATION

LIPOSOMAL FORMULATION

DO NOT SUBSTITUTE

FOR INTRAVENOUS INFUSION ONLY AFTER DILUTION

Rx only

25 mL Single-dose Vial



Carton 25 ml