MedPath

Doxorubicin Hydrochloride Liposome

These highlights do not include all the information needed to use DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION safely and effectively. See full prescribing information for Doxorubicin hydrochloride liposome injection. Doxorubicin Hydrochloride Liposome Injection, for intravenous useInitial U.S. Approval: 1995

Approved
Approval ID

cf25a018-e795-49e4-8533-a581f8366dd9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 31, 2022

Manufacturers
FDA

Baxter Healthcare Company

DUNS: 005083209

FDA

Baxter Healthcare Corporation

DUNS: 005083209

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Doxorubicin Hydrochloride Liposome

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0338-0086
Application NumberNDA050718
Product Classification
M
Marketing Category
C73605
G
Generic Name
Doxorubicin Hydrochloride Liposome
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2022
FDA Product Classification

INGREDIENTS (9)

SODIUM N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINEInactive
Quantity: 3.19 mg in 1 mL
Code: 3L6NN8ZZKU
Classification: IACT
DOXORUBICIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: 82F2G7BL4E
Classification: ACTIB
CHOLESTEROLInactive
Quantity: 3.19 mg in 1 mL
Code: 97C5T2UQ7J
Classification: IACT
AMMONIUM SULFATEInactive
Quantity: 0.6 mg in 1 mL
Code: SU46BAM238
Classification: IACT
HYDROGENATED SOYBEAN LECITHINInactive
Quantity: 9.58 mg in 1 mL
Code: H1109Z9J4N
Classification: IACT
HISTIDINEInactive
Quantity: 1.55 mg in 1 mL
Code: 4QD397987E
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SUCROSEInactive
Quantity: 94 mg in 1 mL
Code: C151H8M554
Classification: IACT

Doxorubicin Hydrochloride Liposome

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0338-0080
Application NumberNDA050718
Product Classification
M
Marketing Category
C73605
G
Generic Name
Doxorubicin Hydrochloride Liposome
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2022
FDA Product Classification

INGREDIENTS (9)

DOXORUBICIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: 82F2G7BL4E
Classification: ACTIB
CHOLESTEROLInactive
Quantity: 3.19 mg in 1 mL
Code: 97C5T2UQ7J
Classification: IACT
SODIUM N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINEInactive
Quantity: 3.19 mg in 1 mL
Code: 3L6NN8ZZKU
Classification: IACT
HYDROGENATED SOYBEAN LECITHINInactive
Quantity: 9.58 mg in 1 mL
Code: H1109Z9J4N
Classification: IACT
AMMONIUM SULFATEInactive
Quantity: 0.6 mg in 1 mL
Code: SU46BAM238
Classification: IACT
HISTIDINEInactive
Quantity: 1.55 mg in 1 mL
Code: 4QD397987E
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SUCROSEInactive
Quantity: 94 mg in 1 mL
Code: C151H8M554
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Doxorubicin Hydrochloride Liposome - FDA Drug Approval Details