Daunorubicin Hydrochloride
DAUNORUBICIN HYDROCHLORIDE INJECTION Rx ONLY
Approved
Approval ID
9705fa12-499e-41a3-8fb4-f6df0858b851
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2021
Manufacturers
FDA
Hisun Pharmaceuticals USA, Inc.
DUNS: 961628505
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
daunorubicin hydrochloride
PRODUCT DETAILS
NDC Product Code42658-019
Application NumberANDA208759
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateFebruary 9, 2021
Generic Namedaunorubicin hydrochloride
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
DAUNORUBICIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: UD984I04LZ
Classification: ACTIM
daunorubicin hydrochloride
PRODUCT DETAILS
NDC Product Code42658-021
Application NumberANDA208759
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateFebruary 9, 2021
Generic Namedaunorubicin hydrochloride
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DAUNORUBICIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: UD984I04LZ
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT