Doxorubicin Hydrochloride
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1974
Approved
Approval ID
971de64b-ff09-4370-afd9-6eb1093ad27d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2024
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxorubicin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9091
Application NumberANDA064097
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxorubicin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
DOXORUBICIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: 82F2G7BL4E
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Doxorubicin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9090
Application NumberANDA062975
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxorubicin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (4)
DOXORUBICIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: 82F2G7BL4E
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Doxorubicin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9089
Application NumberANDA062975
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxorubicin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
DOXORUBICIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: 82F2G7BL4E
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Doxorubicin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9088
Application NumberANDA062975
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxorubicin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (4)
DOXORUBICIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: 82F2G7BL4E
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT