WinRho SDF (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — NDC: 70257-330-11 — 1500 IU Vial Label

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

PRINCIPAL DISPLAY PANEL — NDC: 70257-330-51 — 1500 IU Carton Label

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

PRINCIPAL DISPLAY PANEL — NDC: 70257-350-02 — 2500 IU Vial Label

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

PRINCIPAL DISPLAY PANEL — NDC: 70257-350-51 — 2500 IU Carton Label

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

PRINCIPAL DISPLAY PANEL — NDC: 70257-310-04 — 5000 IU Vial Label

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

PRINCIPAL DISPLAY PANEL — NDC: 70257-310-51 — 5000 IU Carton Label

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

PRINCIPAL DISPLAY PANEL — NDC: 70257-300-13 — 15000 IU Vial Label

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

PRINCIPAL DISPLAY PANEL — NDC: 70257-300-51 — 15000 IU Carton Label

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

WINRHO SDF rho (d) immune globulin injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70257-330
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]
Inactive Ingredients
Ingredient Name Strength
MALTOSE
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70257-330-51 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (70257-330-11)
1 NDC:70257-330-11 1 INJECTION in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70257-330-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 03/01/2019
WINRHO SDF rho (d) immune globulin injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70257-350
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]
Inactive Ingredients
Ingredient Name Strength
MALTOSE
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70257-350-51 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (70257-350-02)
1 NDC:70257-350-02 1 INJECTION in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70257-350-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 03/01/2019
WINRHO SDF rho (d) immune globulin injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70257-310
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]
Inactive Ingredients
Ingredient Name Strength
MALTOSE
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70257-310-51 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (70257-310-04)
1 NDC:70257-310-04 1 INJECTION in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70257-310-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 03/01/2019
WINRHO SDF rho (d) immune globulin injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70257-300
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]
Inactive Ingredients
Ingredient Name Strength
MALTOSE
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70257-300-51 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (70257-300-13)
1 NDC:70257-300-13 1 INJECTION in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70257-300-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 03/01/2019
Labeler — Saol Therapeutics Inc. (080040201)

Revised: 11/2020 Saol Therapeutics Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.