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.

NDC Product Code42658-021

Application NumberANDA208759

Marketing CategoryC73584

Route of AdministrationINTRAVENOUS

Effective DateJanuary 1, 2023

Generic Namedaunorubicin hydrochloride

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