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. IRINOTECAN HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 1996
Approved
Approval ID
d04f2471-3085-4fc8-a657-bb3918d48e6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 8, 2022
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
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 Code50742-402
Application NumberANDA206935
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irinotecan Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 8, 2022
FDA Product Classification
INGREDIENTS (5)
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
IRINOTECAN HYDROCHLORIDEActive
Quantity: 100 mg in 5 mL
Code: 042LAQ1IIS
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Irinotecan Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-401
Application NumberANDA206935
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irinotecan Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 8, 2022
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IRINOTECAN HYDROCHLORIDEActive
Quantity: 40 mg in 2 mL
Code: 042LAQ1IIS
Classification: ACTIB
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT