Epirubicin Hydrochloride
These highlights do not include all the information needed to use Epirubicin Hydrochloride Injection safely and effectively. See full prescribing information for Epirubicin Hydrochloride Injection. Epirubicin Hydrochloride Injection, USP Initial U.S. Approval: 1999
Approved
Approval ID
a24ff5f2-0a9a-4222-9135-1d4094ddd2e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2019
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Epirubicin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9203
Application NumberANDA065289
Product Classification
M
Marketing Category
C73584
G
Generic Name
Epirubicin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 13, 2018
FDA Product Classification
INGREDIENTS (4)
EPIRUBICIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: 22966TX7J5
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Epirubicin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9202
Application NumberANDA065289
Product Classification
M
Marketing Category
C73584
G
Generic Name
Epirubicin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 13, 2018
FDA Product Classification
INGREDIENTS (4)
EPIRUBICIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: 22966TX7J5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT