ACTEMRA (Page 15 of 15)

PRINCIPAL DISPLAY PANEL — 4 mL Vial Box

NDC 50242-135-01

Actemra®
(tocilizumab)
Injection

80 mg/4 mL

(20 mg/mL)

For Intravenous Infusion only after
dilution.
Single-Dose Vial; Discard unused portion

ATTENTION PROVIDER: Each patient is
required to receive the enclosedMedication Guide

No Preservative

Rx only

Genentech

10241776

PRINCIPAL DISPLAY PANEL -- 4 mL Vial Box
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL Vial Box

NDC 50242-136-01

Actemra®
(tocilizumab)
Injection

200 mg/10 mL

(20 mg/mL)

For Intravenous Infusion only after
dilution.
Single-Dose Vial; Discard unused portion

ATTENTION PROVIDER: Each patient is
required to receive the enclosedMedication Guide

No Preservative

Rx only

Genentech

10241771

Principal Display Panel -- 10 mL Vial Box
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mL Vial Box

NDC 50242-137-01

Actemra®
(tocilizumab)
Injection

400 mg/20 mL

(20 mg/mL)

For Intravenous Infusion only after
dilution.
Single-Dose Vial; Discard unused portion

ATTENTION PROVIDER: Each patient is
required to receive the enclosedMedication Guide

No Preservative

Rx only

Genentech

10241779

Principal Display Panel -- 20 mL Vial Box
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.9 mL Syringe Box

NDC 50242-138-01

Rx only

Actemra®
(tocilizumab)
Injection

162 mg / 0.9 mL

For Subcutaneous
Injection Only

Single Dose Prefilled
Syringe — Discard Unused
Portion

Sterile

ATTENTION
PHARMACIST:
Each patient is required
to receive the enclosed
Medication Guide.

Refrigerate Immediately

Each Prefilled Syringe
Contains: 162 mg/0.9 mL

Genentech

⬇ TO OPEN ⬇

10249853

PRINCIPAL DISPLAY PANEL -- 0.9 mL Syringe Box
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.9 mL Autoinjector Box

NDC 50242-143-01

Rx only

Actemra®
ACTPen®
(tocilizumab)
Injection

162 mg / 0.9 mL

For Subcutaneous
Injection Only

Sterile

ATTENTION
PHARMACIST:
Each patient is required
to receive the enclosed
Medication Guide.

Refrigerate Immediately

CAUTION

Injection is
complete only
when
the purple
indicator stops
moving.
This may take up
to 10 seconds.
Refer to
instructions for
use.

1 Single-dose
Autoinjector
Discard Unused or Expired Portion

Genentech

⬇ TO OPEN ⬇

10249859

PRINCIPAL DISPLAY PANEL -- 0.9 mL Autoinjector Box
(click image for full-size original)
ACTEMRA tocilizumab injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-135
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOCILIZUMAB (TOCILIZUMAB) TOCILIZUMAB 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
POLYSORBATE 80
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-135-01 1 VIAL, SINGLE-USE in 1 BOX contains a VIAL, SINGLE-USE
1 4 mL in 1 VIAL, SINGLE-USE This package is contained within the BOX (50242-135-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125276 01/08/2010
ACTEMRA tocilizumab injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-136
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOCILIZUMAB (TOCILIZUMAB) TOCILIZUMAB 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
POLYSORBATE 80
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-136-01 1 VIAL, SINGLE-USE in 1 BOX contains a VIAL, SINGLE-USE
1 10 mL in 1 VIAL, SINGLE-USE This package is contained within the BOX (50242-136-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125276 01/08/2010
ACTEMRA tocilizumab injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-137
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOCILIZUMAB (TOCILIZUMAB) TOCILIZUMAB 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
POLYSORBATE 80
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-137-01 1 VIAL, SINGLE-USE in 1 BOX contains a VIAL, SINGLE-USE
1 20 mL in 1 VIAL, SINGLE-USE This package is contained within the BOX (50242-137-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125276 01/08/2010
ACTEMRA tocilizumab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-138
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOCILIZUMAB (TOCILIZUMAB) TOCILIZUMAB 180 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80
HISTIDINE
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
ARGININE HYDROCHLORIDE
METHIONINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-138-01 1 SYRINGE, GLASS in 1 BOX contains a SYRINGE, GLASS
1 0.9 mL in 1 SYRINGE, GLASS This package is contained within the BOX (50242-138-01)
2 NDC:50242-138-86 1 SYRINGE, GLASS in 1 BOX contains a SYRINGE, GLASS
2 0.9 mL in 1 SYRINGE, GLASS This package is contained within the BOX (50242-138-86)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125472 10/21/2013
ACTEMRA ACTPEN tocilizumab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-143
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOCILIZUMAB (TOCILIZUMAB) TOCILIZUMAB 180 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80
HISTIDINE
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
ARGININE HYDROCHLORIDE
METHIONINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-143-01 1 SYRINGE, GLASS in 1 BOX contains a SYRINGE, GLASS
1 0.9 mL in 1 SYRINGE, GLASS This package is contained within the BOX (50242-143-01)
2 NDC:50242-143-86 1 SYRINGE, GLASS in 1 BOX contains a SYRINGE, GLASS
2 0.9 mL in 1 SYRINGE, GLASS This package is contained within the BOX (50242-143-86)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125472 11/19/2018
Labeler — Genentech, Inc. (080129000)
Registrant — Genentech, Inc. (080129000)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche Ltd 485244961 ANALYSIS (50242-135), ANALYSIS (50242-136), ANALYSIS (50242-137), ANALYSIS (50242-138), ANALYSIS (50242-143), LABEL (50242-135), LABEL (50242-136), LABEL (50242-137), LABEL (50242-138), LABEL (50242-143), PACK (50242-135), PACK (50242-136), PACK (50242-137), PACK (50242-138), PACK (50242-143)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. 146373191 ANALYSIS (50242-135), ANALYSIS (50242-136), ANALYSIS (50242-137), ANALYSIS (50242-138), ANALYSIS (50242-143), API MANUFACTURE (50242-135), API MANUFACTURE (50242-136), API MANUFACTURE (50242-137), API MANUFACTURE (50242-138), API MANUFACTURE (50242-143)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. 080129000 ANALYSIS (50242-135), ANALYSIS (50242-136), ANALYSIS (50242-137), ANALYSIS (50242-138), ANALYSIS (50242-143)
Establishment
Name Address ID/FEI Operations
Roche Diagnostics GmbH 323105205 ANALYSIS (50242-135), ANALYSIS (50242-136), ANALYSIS (50242-137), ANALYSIS (50242-138), ANALYSIS (50242-143)
Establishment
Name Address ID/FEI Operations
Roche Singapore Technical Operations Pte. Ltd. 937189173 ANALYSIS (50242-135), ANALYSIS (50242-136), ANALYSIS (50242-137), ANALYSIS (50242-138), ANALYSIS (50242-143)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. 833220176 MANUFACTURE (50242-137), PACK (50242-137), LABEL (50242-137), ANALYSIS (50242-137)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. 004074162 ANALYSIS (50242-135), ANALYSIS (50242-136), ANALYSIS (50242-137), ANALYSIS (50242-138), ANALYSIS (50242-143), API MANUFACTURE (50242-135), API MANUFACTURE (50242-136), API MANUFACTURE (50242-137), API MANUFACTURE (50242-138), API MANUFACTURE (50242-143)
Establishment
Name Address ID/FEI Operations
Roche Diagnostics GmbH 315028860 ANALYSIS (50242-135), ANALYSIS (50242-136), ANALYSIS (50242-137), ANALYSIS (50242-138), ANALYSIS (50242-143)

Revised: 06/2022 Genentech, Inc.

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