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ERBITUX

These highlights do not include all the information needed to use ERBITUX safely and effectively. See full prescribing information for ERBITUX.ERBITUX (cetuximab) injection, for intravenous useInitial U.S. Approval: 2004

Approved
Approval ID

8bc6397e-4bd8-4d37-a007-a327e4da34d9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 22, 2023

Manufacturers
FDA

ImClone LLC

DUNS: 832474493

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

cetuximab

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66733-958
Application NumberBLA125084
Product Classification
M
Marketing Category
C73585
G
Generic Name
cetuximab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 13, 2022
FDA Product Classification

INGREDIENTS (8)

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 1.88 mg in 1 mL
Code: 70WT22SF4B
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 0.41 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
cetuximabActive
Quantity: 2 mg in 1 mL
Code: PQX0D8J21J
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 8.48 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT

cetuximab

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66733-948
Application NumberBLA125084
Product Classification
M
Marketing Category
C73585
G
Generic Name
cetuximab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 13, 2022
FDA Product Classification

INGREDIENTS (8)

cetuximabActive
Quantity: 2 mg in 1 mL
Code: PQX0D8J21J
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 1.88 mg in 1 mL
Code: 70WT22SF4B
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.48 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 0.41 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

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ERBITUX - FDA Drug Approval Details