WINRHO (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — NDC: 70504-3300-1 — 1500 IU (300 µg) Vial Label

1500 IU (300 µg) Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 70504-3300-2 — 1500 IU (300 µg) Carton Label

1500 IU (300 µg) Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 70504-3500-1 — 2500 IU (500 µg) Vial Label

2500 IU (500 µg) Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 70504-3500-2 — 2500 IU (500 µg) Carton Label

2500 IU (500 µg) Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 70504-3100-1 — 5000 IU (1000 µg) Vial Label

5000 IU (1000 µg) Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 70504-3100-2 — 5000 IU (1000 µg) Carton Label

5000 IU (1000 µg) Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 70504-3000-1 — 15000 IU (3000 µg) Vial Label

15000 IU (3000 µg) Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 70504-3000-2 — 15000 IU (3000 µg) Carton Label

15000 IU (3000 µg) Carton Label
(click image for full-size original)

WINRHO rho (d) immune globulin liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70504-3300
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN RHO(D) IMMUNE GLOBULIN (HUMAN RHO(D) IMMUNE GLOBULIN) HUMAN RHO(D) IMMUNE GLOBULIN 1500 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
MALTOSE
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70504-3300-2 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (70504-3300-1)
1 NDC:70504-3300-1 1.3 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70504-3300-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 07/01/2016
WINRHO rho (d) immune globulin liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70504-3500
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN RHO(D) IMMUNE GLOBULIN (HUMAN RHO(D) IMMUNE GLOBULIN) HUMAN RHO(D) IMMUNE GLOBULIN 2500 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
MALTOSE
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70504-3500-2 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (70504-3500-1)
1 NDC:70504-3500-1 2.2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70504-3500-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 07/01/2016
WINRHO rho (d) immune globulin liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70504-3100
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN RHO(D) IMMUNE GLOBULIN (HUMAN RHO(D) IMMUNE GLOBULIN) HUMAN RHO(D) IMMUNE GLOBULIN 5000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
MALTOSE
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70504-3100-2 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (70504-3100-1)
1 NDC:70504-3100-1 4.4 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70504-3100-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 07/01/2016
WINRHO rho (d) immune globulin liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70504-3000
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN RHO(D) IMMUNE GLOBULIN (HUMAN RHO(D) IMMUNE GLOBULIN) HUMAN RHO(D) IMMUNE GLOBULIN 15000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
MALTOSE
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70504-3000-2 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (70504-3000-1)
1 NDC:70504-3000-1 13 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70504-3000-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 07/01/2016
Labeler — Aptevo BioTherapeutics LLC (080160602)

Revised: 10/2019 Aptevo BioTherapeutics LLC

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