NDC Code(s) : 50242-135-01, 50242-136-01, 50242-137-01, 50242-138-01, 50242-138-86, 50242-143-01, 50242-143-86
Packager : Genentech, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACTEMRAtocilizumab 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(UNII: I031V2H011)
(TOCILIZUMAB - UNII:I031V2H011) 		TOCILIZUMAB80 mg in 4 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE(UNII: E1W4N241FO)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE(UNII: 5QWK665956)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50242-135-011 in 1 BOX 01/08/2010
14 mL in 1 VIAL, SINGLE-USE TYPE 0: NOT A COMBINATION PRODUCT
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125276 01/08/2010
ACTEMRAtocilizumab 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(UNII: I031V2H011)
(TOCILIZUMAB - UNII:I031V2H011) 		TOCILIZUMAB200 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE(UNII: E1W4N241FO)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE(UNII: 5QWK665956)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50242-136-011 in 1 BOX 01/08/2010
110 mL in 1 VIAL, SINGLE-USE TYPE 0: NOT A COMBINATION PRODUCT
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125276 01/08/2010
ACTEMRAtocilizumab 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(UNII: I031V2H011)
(TOCILIZUMAB - UNII:I031V2H011) 		TOCILIZUMAB400 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE(UNII: E1W4N241FO)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE(UNII: 5QWK665956)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50242-137-011 in 1 BOX 01/08/2010
120 mL in 1 VIAL, SINGLE-USE TYPE 0: NOT A COMBINATION PRODUCT
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125276 01/08/2010
Actemratocilizumab 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(UNII: I031V2H011)
(TOCILIZUMAB - UNII:I031V2H011) 		TOCILIZUMAB162 mg in 0.9 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HISTIDINE(UNII: 4QD397987E)
HISTIDINE HYDROCHLORIDE MONOHYDRATE(UNII: X573657P6P)
ARGININE HYDROCHLORIDE(UNII: F7LTH1E20Y)
METHIONINE(UNII: AE28F7PNPL)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50242-138-011 in 1 BOX 21/10/2013
10.9 mL in 1 SYRINGE, GLASS TYPE 3: PREFILLED BIOLOGIC DELIVERY DEVICE/SYSTEM (SYRINGE, PATCH, ETC.)
2NDC:50242-138-861 in 1 BOX 21/10/2013
20.9 mL in 1 SYRINGE, GLASS TYPE 3: PREFILLED BIOLOGIC DELIVERY DEVICE/SYSTEM (SYRINGE, PATCH, ETC.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125472 10/21/2013
Actemra ACTPentocilizumab 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(UNII: I031V2H011)
(TOCILIZUMAB - UNII:I031V2H011) 		TOCILIZUMAB162 mg in 0.9 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HISTIDINE(UNII: 4QD397987E)
HISTIDINE HYDROCHLORIDE MONOHYDRATE(UNII: X573657P6P)
ARGININE HYDROCHLORIDE(UNII: F7LTH1E20Y)
METHIONINE(UNII: AE28F7PNPL)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50242-143-011 in 1 BOX 19/11/2018
10.9 mL in 1 SYRINGE, GLASS TYPE 3: PREFILLED BIOLOGIC DELIVERY DEVICE/SYSTEM (SYRINGE, PATCH, ETC.)
2NDC:50242-143-861 in 1 BOX 19/11/2018
20.9 mL in 1 SYRINGE, GLASS TYPE 3: PREFILLED BIOLOGIC DELIVERY DEVICE/SYSTEM (SYRINGE, PATCH, ETC.)
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 Business Operations
F. Hoffmann-La Roche AG 485244961 ANALYSIS(50242-135, 50242-136, 50242-137, 50242-138, 50242-143), PACK(50242-135, 50242-136, 50242-137, 50242-138, 50242-143), LABEL(50242-135, 50242-136, 50242-137, 50242-138, 50242-143)

Establishment
Name Address ID/FEI Business Operations
Genentech, Inc. (Oceanside) 146373191 API MANUFACTURE(50242-135, 50242-136, 50242-137, 50242-138, 50242-143), ANALYSIS(50242-135, 50242-136, 50242-137, 50242-138, 50242-143)

Establishment
Name Address ID/FEI Business Operations
Roche Diagnostics GmbH 323105205 ANALYSIS(50242-135, 50242-136, 50242-137, 50242-138, 50242-143)

Establishment
Name Address ID/FEI Business Operations
Genentech, Inc. (Hillsboro) 833220176 LABEL(50242-137), PACK(50242-137), MANUFACTURE(50242-137), ANALYSIS(50242-137)

Establishment
Name Address ID/FEI Business Operations
Roche Diagnostics GmbH 315028860 ANALYSIS(50242-135, 50242-136, 50242-137, 50242-138, 50242-143), PACK(50242-135, 50242-136, 50242-137, 50242-138, 50242-143), LABEL(50242-135, 50242-136, 50242-137, 50242-138, 50242-143)

PRINCIPAL DISPLAY PANEL

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 enclosed
Medication Guide
No Preservative

Rx only

Genentech

11037819

PRINCIPAL DISPLAY PANEL - 80 mg/4 mL Vial Carton

PRINCIPAL DISPLAY PANEL

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 enclosed
Medication Guide
No Preservative

Rx only

Genentech

11037833

PRINCIPAL DISPLAY PANEL - 200 mg/10 mL Vial Carton

PRINCIPAL DISPLAY PANEL

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 enclosed
Medication Guide
No Preservative

Rx only

Genentech

11037818

PRINCIPAL DISPLAY PANEL - 400 mg/20 mL Vial Carton

PRINCIPAL DISPLAY PANEL

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 - 162 mg/0.9 mL Prefilled Syringe Carton

PRINCIPAL DISPLAY PANEL

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 - 162 mg/0.9 mL Autoinjector Carton