Rituxan Hycela (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 11.7 mL Vial Carton

Rx only

NDC 50242-108-01

Rituxan Hycela®
(rituximab and
hyaluronidase human)
Injection

1,400 mg and
23,400 Units/11.7 mL
(120 mg and 2,000 Units/mL)

For Subcutaneous Use Only.
Give the subcutaneous
injection over 5 to 7 minutes.

Single-Dose Vial.
Discard Unused Portion.

Attention Pharmacist: Dispense the
accompanying Medication Guide to each patient.

1 vial

Genentech | Biogen®

10214985

PRINCIPAL DISPLAY PANEL -- 11.7 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 13.4 mL Vial Carton

Rx only

NDC 50242-109-01

Rituxan Hycela®
(rituximab and
hyaluronidase human)
Injection

1,600 mg and
26,800 Units/13.4 mL
(120 mg and 2,000 Units/mL)

For Subcutaneous Use Only.
Give the subcutaneous
injection over 5 to 7 minutes.

Single-Dose Vial.
Discard Unused Portion.

Attention Pharmacist: Dispense the
accompanying Medication Guide to each patient.

1 vial

Genentech | Biogen®

10214988

PRINCIPAL DISPLAY PANEL -- 13.4 mL Vial Carton
(click image for full-size original)
RITUXAN HYCELA rituximab and hyaluronidase injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-108
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RITUXIMAB (RITUXIMAB) RITUXIMAB 120 mg in 1 mL
HYALURONIDASE (HUMAN RECOMBINANT) (HYALURONIDASE (HUMAN RECOMBINANT)) HYALURONIDASE (HUMAN RECOMBINANT) 2000 U in 1 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
TREHALOSE DIHYDRATE
METHIONINE
POLYSORBATE 80
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-108-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 11.7 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (50242-108-01)
2 NDC:50242-108-86 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
2 11.7 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (50242-108-86)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761064 06/22/2017
RITUXAN HYCELA rituximab and hyaluronidase injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-109
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RITUXIMAB (RITUXIMAB) RITUXIMAB 120 mg in 1 mL
HYALURONIDASE (HUMAN RECOMBINANT) (HYALURONIDASE (HUMAN RECOMBINANT)) HYALURONIDASE (HUMAN RECOMBINANT) 2000 U in 1 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
TREHALOSE DIHYDRATE
METHIONINE
POLYSORBATE 80
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-109-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 13.4 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (50242-109-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761064 06/22/2017
Labeler — Genentech, Inc. (080129000)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. 004074162 ANALYSIS (50242-108), ANALYSIS (50242-109), API MANUFACTURE (50242-108), API MANUFACTURE (50242-109)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche Ltd 485244961 MANUFACTURE (50242-108), MANUFACTURE (50242-109), ANALYSIS (50242-108), ANALYSIS (50242-109), LABEL (50242-108), LABEL (50242-109), PACK (50242-108), PACK (50242-109)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. 080129000 ANALYSIS (50242-108), ANALYSIS (50242-109)
Establishment
Name Address ID/FEI Operations
Roche Singapore Technical Operations Pte. Ltd. (RSTO) 937189173 ANALYSIS (50242-108), ANALYSIS (50242-109)
Establishment
Name Address ID/FEI Operations
Roche Diagnostics GmbH 323105205 ANALYSIS (50242-108), ANALYSIS (50242-109)
Establishment
Name Address ID/FEI Operations
Genentech, Inc 146373191 ANALYSIS (50242-108), ANALYSIS (50242-109)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche AG 482242971 ANALYSIS (50242-108), ANALYSIS (50242-109)

Revised: 12/2019 Genentech, Inc.

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