ACTEMRA
These highlights do not include all the information needed to use ACTEMRA safely and effectively. See full prescribing information for ACTEMRA. ACTEMRA (tocilizumab) injection, for intravenous or subcutaneous use Initial U.S. Approval: 2010
Approved
Approval ID
2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2022
Manufacturers
FDA
Genentech, Inc.
DUNS: 080129000
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tocilizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-137
Application NumberBLA125276
Product Classification
M
Marketing Category
C73585
G
Generic Name
tocilizumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 23, 2022
FDA Product Classification
INGREDIENTS (5)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TOCILIZUMABActive
Quantity: 400 mg in 20 mL
Code: I031V2H011
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEInactive
Code: E1W4N241FO
Classification: IACT
tocilizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-138
Application NumberBLA125472
Product Classification
M
Marketing Category
C73585
G
Generic Name
tocilizumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 23, 2022
FDA Product Classification
INGREDIENTS (7)
TOCILIZUMABActive
Quantity: 162 mg in 0.9 mL
Code: I031V2H011
Classification: ACTIB
ARGININE HYDROCHLORIDEInactive
Code: F7LTH1E20Y
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
tocilizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-136
Application NumberBLA125276
Product Classification
M
Marketing Category
C73585
G
Generic Name
tocilizumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 23, 2022
FDA Product Classification
INGREDIENTS (5)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TOCILIZUMABActive
Quantity: 200 mg in 10 mL
Code: I031V2H011
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEInactive
Code: E1W4N241FO
Classification: IACT
tocilizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-135
Application NumberBLA125276
Product Classification
M
Marketing Category
C73585
G
Generic Name
tocilizumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 23, 2022
FDA Product Classification
INGREDIENTS (5)
TOCILIZUMABActive
Quantity: 80 mg in 4 mL
Code: I031V2H011
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEInactive
Code: E1W4N241FO
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
tocilizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-143
Application NumberBLA125472
Product Classification
M
Marketing Category
C73585
G
Generic Name
tocilizumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 23, 2022
FDA Product Classification
INGREDIENTS (7)
TOCILIZUMABActive
Quantity: 162 mg in 0.9 mL
Code: I031V2H011
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Code: F7LTH1E20Y
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT