Daunorubicin Hydrochloride
DAUNORUBICIN HYDROCHLORIDE INJECTION Rx ONLY
Approved
Approval ID
f4312095-3c21-296b-e053-2995a90a0d9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2023
Manufacturers
FDA
Hisun Pharmaceuticals USA, Inc.
DUNS: 961628505
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
daunorubicin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42658-021
Application NumberANDA208759
Product Classification
M
Marketing Category
C73584
G
Generic Name
daunorubicin hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DAUNORUBICIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: UD984I04LZ
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT