Irinotecan hydrochloide
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. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996
Approved
Approval ID
de634e80-328a-4473-b395-0172683a2411
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 3, 2022
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 2
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 Code68083-382
Application NumberANDA212993
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irinotecan hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 3, 2022
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IRINOTECAN HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 042LAQ1IIS
Classification: ACTIB
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
Irinotecan hydrochloide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-381
Application NumberANDA212993
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irinotecan hydrochloide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 3, 2022
FDA Product Classification
INGREDIENTS (5)
IRINOTECAN HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 042LAQ1IIS
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT