Irinotecan Hydrochloride
These highlights do not include all the information needed to use irinotecan hydrochloride injection safely and effectively. See full prescribing information for Irinotecan Hydrochloride Injection, USP. Irinotecan Hydrochloride Injection, USP Initial U.S. Approval: 1996
Approved
Approval ID
9c6aa884-750e-4b11-9955-bc7ab6e9c2ad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 2020
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Irinotecan Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9583
Application NumberANDA091032
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irinotecan Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 28, 2020
FDA Product Classification
INGREDIENTS (6)
IRINOTECAN HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 042LAQ1IIS
Classification: ACTIB
LACTIC ACIDInactive
Quantity: 0.9 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
SORBITOLInactive
Quantity: 45 mg in 1 mL
Code: 506T60A25R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT