Idarubicin Hydrochloride
Idarubicin Hydrochloride Injection
Approved
Approval ID
7c20b574-285b-49eb-a98e-6752e4bb481d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2019
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Idarubicin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9307
Application NumberANDA065275
Product Classification
M
Marketing Category
C73584
G
Generic Name
Idarubicin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (4)
GLYCERINInactive
Quantity: 25 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IDARUBICIN HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 5VV3MDU5IE
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Idarubicin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9306
Application NumberANDA065275
Product Classification
M
Marketing Category
C73584
G
Generic Name
Idarubicin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IDARUBICIN HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 5VV3MDU5IE
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 25 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
Idarubicin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9308
Application NumberANDA065275
Product Classification
M
Marketing Category
C73584
G
Generic Name
Idarubicin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (4)
IDARUBICIN HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 5VV3MDU5IE
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GLYCERINInactive
Quantity: 25 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT