Doxorubicin Hydrochloride
These highlights do not include all the information needed to use DOXORUBICIN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DOXORUBICIN HYDROCHLORIDE INJECTION. DOXORUBICIN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1974
Approved
Approval ID
8fa04d6d-ac9f-437a-9891-fed0d90a789d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2017
Manufacturers
FDA
Athenex Pharmaceutical Division, LLC.
DUNS: 080318964
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
doxorubicin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70860-208
Application NumberANDA209825
Product Classification
M
Marketing Category
C73584
G
Generic Name
doxorubicin hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 20, 2017
FDA Product Classification
INGREDIENTS (4)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
doxorubicin hydrochlorideActive
Quantity: 2 mg in 1 mL
Code: 82F2G7BL4E
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT