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Irinotecan Hydrochloride

HIGHLIGHTS OF PRESCRIBING INFORMATION 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

82e95139-6222-f73d-e053-2a91aa0a4810

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 14, 2021

Manufacturers
FDA

Areva Pharmaceuticals, Inc.

DUNS: 833189835

Products 3

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 Code59923-715
Application NumberANDA208718
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irinotecan Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 14, 2021
FDA Product Classification

INGREDIENTS (6)

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

Irinotecan Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59923-714
Application NumberANDA208718
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irinotecan Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 14, 2021
FDA Product Classification

INGREDIENTS (6)

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

Irinotecan Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59923-716
Application NumberANDA208718
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irinotecan Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 14, 2021
FDA Product Classification

INGREDIENTS (6)

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

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Irinotecan Hydrochloride - FDA Drug Approval Details