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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

afcdde49-ec0c-4c56-a1af-2917185b1a08

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 10, 2021

Manufacturers
FDA

Qilu Pharmaceutical Co., Ltd.

DUNS: 653878256

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 Code67184-0512
Application NumberANDA203380
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irinotecan Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 15, 2020
FDA Product Classification

INGREDIENTS (6)

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

Irinotecan Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67184-0513
Application NumberANDA203380
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irinotecan Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 15, 2020
FDA Product Classification

INGREDIENTS (6)

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

Irinotecan Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67184-0511
Application NumberANDA203380
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irinotecan Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 15, 2020
FDA Product Classification

INGREDIENTS (6)

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

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Irinotecan Hydrochloride - FDA Drug Approval Details