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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 use Initial U.S. Approval: 1996

Approved
Approval ID

7a30d551-9ea7-47ea-9073-f541bff457a3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 25, 2023

Manufacturers
FDA

Eugia US LLC

DUNS: 968961354

Products 4

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 Code55150-352
Application NumberANDA213278
Product Classification
M
Marketing Category
C73584
G
Generic Name
IRINOTECAN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 25, 2023
FDA Product Classification

INGREDIENTS (6)

IRINOTECAN HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 042LAQ1IIS
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

IRINOTECAN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-353
Application NumberANDA213278
Product Classification
M
Marketing Category
C73584
G
Generic Name
IRINOTECAN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 25, 2023
FDA Product Classification

INGREDIENTS (6)

SORBITOLInactive
Code: 506T60A25R
Classification: IACT
IRINOTECAN HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 042LAQ1IIS
Classification: ACTIB
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

IRINOTECAN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-355
Application NumberANDA213278
Product Classification
M
Marketing Category
C73584
G
Generic Name
IRINOTECAN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 25, 2023
FDA Product Classification

INGREDIENTS (6)

SORBITOLInactive
Code: 506T60A25R
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
IRINOTECAN HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 042LAQ1IIS
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

IRINOTECAN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-354
Application NumberANDA213278
Product Classification
M
Marketing Category
C73584
G
Generic Name
IRINOTECAN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 25, 2023
FDA Product Classification

INGREDIENTS (6)

SORBITOLInactive
Code: 506T60A25R
Classification: IACT
IRINOTECAN HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 042LAQ1IIS
Classification: ACTIB
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

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