Idarubicin Hydrochloride
Idarubicin Hydrochloride Injection
Approved
Approval ID
b9b337d5-50f7-4ea9-9df4-72c86e4c0b91
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2023
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 Code0143-9219
Application NumberANDA065275
Product Classification
M
Marketing Category
C73584
G
Generic Name
Idarubicin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 19, 2023
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
Idarubicin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9218
Application NumberANDA065275
Product Classification
M
Marketing Category
C73584
G
Generic Name
Idarubicin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IDARUBICIN HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 5VV3MDU5IE
Classification: ACTIB
GLYCERINInactive
Quantity: 25 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Idarubicin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9217
Application NumberANDA065275
Product Classification
M
Marketing Category
C73584
G
Generic Name
Idarubicin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (4)
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
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT