Xyntha: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 1000 IU Syringe Label

NDC 58394-124-03
Rx only
Xyntha^® Solofuse^®

Antihemophilic Factor
(Recombinant)
For IV Administration
Dual-Chamber Syringe
No Preservatives. Single Use.

Refrigerate. Protect from light.
Manufactured by
Wyeth Pharmaceuticals LLC
A subsidiary of Pfizer Inc.
Philadelphia, PA 19101US Govt. License No. 3

1000 IU Range

For Factor VIII Replacement

PRINCIPAL DISPLAY PANEL — Kit Carton — 1000 IU

One Single-Use, Prefilled Dual-Chamber Syringe
NDC 58394-024-03
1000 IU Range

xyntha^® solofuse^®
Antihemophilic Factor (Recombinant)

Single-Use,
Dual-Chamber
Syringe, Prefilled
with XYNTHA
and Diluent
For Factor VIII Replacement
Therapy Only

For Intravenous Administration.Rx only

Pfizer

PRINCIPAL DISPLAY PANEL — 250 IU Syringe Label

NDC 58394-122-03
Rx only
Xyntha^® Solofuse^®

Antihemophilic Factor
(Recombinant)
For IV Administration
Dual-Chamber Syringe
No Preservatives. Single Use.

Refrigerate. Protect from light.
Manufactured by
Wyeth Pharmaceuticals LLC
A subsidiary of Pfizer Inc.
Philadelphia, PA 19101US Govt. License No. 3

250 IU Range

For Factor VIII Replacement

PRINCIPAL DISPLAY PANEL — Kit Carton — 250 IU

One Single-Use, Prefilled Dual-Chamber Syringe
NDC 58394-022-03
250 IU Range

xyntha^® solofuse^®
Antihemophilic Factor (Recombinant)

Single-Use,
Dual-Chamber
Syringe, Prefilled
with XYNTHA
and Diluent
For Factor VIII Replacement
Therapy Only

For Intravenous Administration.Rx only

Pfizer

PRINCIPAL DISPLAY PANEL — 500 IU Syringe Label

NDC 58394-123-03
Rx only
Xyntha^® Solofuse^®

Antihemophilic Factor
(Recombinant)
For IV Administration
Dual-Chamber Syringe
No Preservatives. Single Use.

Refrigerate. Protect from light.
Manufactured by
Wyeth Pharmaceuticals LLC
A subsidiary of Pfizer Inc.
Philadelphia, PA 19101US Govt. License No. 3

500 IU Range

For Factor VIII Replacement

PRINCIPAL DISPLAY PANEL — Kit Carton — 500 IU

One Single-Use, Prefilled Dual-Chamber Syringe
NDC 58394-023-03
500 IU Range

xyntha^® solofuse^®
Antihemophilic Factor (Recombinant)

Single-Use,
Dual-Chamber
Syringe, Prefilled
with XYNTHA
and Diluent
For Factor VIII Replacement
Therapy Only

For Intravenous Administration.Rx only

Pfizer

PRINCIPAL DISPLAY PANEL — 2000 IU Syringe Label

NDC 58394-125-03
Xyntha^® Solofuse^®
Rx only

Antihemophilic Factor
(Recombinant)
For IV Administration
Dual-Chamber Syringe
No Preservatives. Single Use.

Refrigerate. Protect from light.
Manufactured by
Wyeth Pharmaceuticals LLC
A subsidiary of Pfizer Inc.
Philadelphia, PA 19101US Govt. License No. 3

2000 IU Range

For Factor VIII Replacement

PRINCIPAL DISPLAY PANEL — Kit Carton — 2000 IU

One Single-Use, Prefilled Dual-Chamber Syringe
NDC 58394-025-03
2000 IU Range

xyntha^® solofuse^®
Antihemophilic Factor (Recombinant)

Single-Use,
Dual-Chamber
Syringe, Prefilled
with XYNTHA
and Diluent
For Factor VIII Replacement
Therapy Only

For Intravenous Administration.Rx only

Pfizer

PRINCIPAL DISPLAY PANEL — 3000 IU Syringe Label

NDC 58394-116-03
Rx only
Xyntha^® Solofuse^®

Antihemophilic Factor
(Recombinant)
For IV Administration
Dual-Chamber Syringe
No Preservatives. Single Use.

Refrigerate. Protect from light.
Manufactured by
Wyeth Pharmaceuticals LLC
A subsidiary of Pfizer Inc.
Philadelphia, PA 19101US Govt. License No. 3

3000 IU Range

For Factor VIII Replacement

PRINCIPAL DISPLAY PANEL — Kit Carton — 3000 IU

One Single-Use, Prefilled Dual-Chamber Syringe
NDC 58394-016-03
3000 IU Range

xyntha^® solofuse^®
Antihemophilic Factor (Recombinant)

Single-Use,
Dual-Chamber
Syringe, Prefilled
with XYNTHA
and Diluent
For Factor VIII Replacement
Therapy Only

For Intravenous Administration.Rx only

Pfizer

XYNTHA antihemophilic factor (recombinant) kit

Product Information Product Type Item Code (Source) NDC:58394-024

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58394-024-03 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 SYRINGE 4 mL Part 2 2 PACKET 2 mL

Part 1 of 2 XYNTHA antihemophilic factor (recombinant) injection, powder, lyophilized, for solution

Product Information Item Code (Source) NDC:58394-124 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MOROCTOCOG ALFA (MOROCTOCOG ALFA) MOROCTOCOG ALFA 1000 [iU] in 4 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.036 mg in 4 mL SUCROSE HISTIDINE CALCIUM CHLORIDE POLYSORBATE 80 WATER 4 mL in 4 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58394-124-03 4 mL in 1 SYRINGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125264 08/01/2011

Part 2 of 2 ALCOHOL alcohol swab

Product Information Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 1 mL in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 08/01/2011

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125264 08/01/2011

XYNTHA antihemophilic factor (recombinant) kit

Product Information Product Type Item Code (Source) NDC:58394-022

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58394-022-03 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 SYRINGE 4 mL Part 2 2 PACKET 2 mL

Part 1 of 2 XYNTHA antihemophilic factor (recombinant) injection, powder, lyophilized, for solution

Product Information Item Code (Source) NDC:58394-122 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MOROCTOCOG ALFA (MOROCTOCOG ALFA) MOROCTOCOG ALFA 250 [iU] in 4 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.036 mg in 4 mL SUCROSE HISTIDINE CALCIUM CHLORIDE POLYSORBATE 80 WATER 4 mL in 4 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58394-122-03 4 mL in 1 SYRINGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125264 12/01/2011

Part 2 of 2 ALCOHOL alcohol swab

Product Information Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 1 mL in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 12/01/2011

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125264 12/01/2011

XYNTHA antihemophilic factor (recombinant) kit

Product Information Product Type Item Code (Source) NDC:58394-023

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58394-023-03 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 SYRINGE 4 mL Part 2 2 PACKET 2 mL

Part 1 of 2 XYNTHA antihemophilic factor (recombinant) injection, powder, lyophilized, for solution

Product Information Item Code (Source) NDC:58394-123 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MOROCTOCOG ALFA (MOROCTOCOG ALFA) MOROCTOCOG ALFA 500 [iU] in 4 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.036 mg in 4 mL SUCROSE HISTIDINE CALCIUM CHLORIDE POLYSORBATE 80 WATER 4 mL in 4 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58394-123-03 4 mL in 1 SYRINGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125264 12/01/2011

Part 2 of 2 ALCOHOL alcohol swab

Product Information Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 1 mL in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 12/01/2011

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125264 12/01/2011

XYNTHA antihemophilic factor (recombinant) kit

Product Information Product Type Item Code (Source) NDC:58394-025

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58394-025-03 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 SYRINGE 4 mL Part 2 2 PACKET 2 mL

Part 1 of 2 XYNTHA antihemophilic factor (recombinant) injection, powder, lyophilized, for solution

Product Information Item Code (Source) NDC:58394-125 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MOROCTOCOG ALFA (MOROCTOCOG ALFA) MOROCTOCOG ALFA 2000 [iU] in 4 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.036 mg in 4 mL SUCROSE HISTIDINE CALCIUM CHLORIDE POLYSORBATE 80 WATER 4 mL in 4 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58394-125-03 4 mL in 1 SYRINGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125264 08/01/2011

Part 2 of 2 ALCOHOL alcohol swab

Product Information Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 1 mL in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 08/01/2011

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125264 08/01/2011

XYNTHA antihemophilic factor (recombinant) kit

Product Information Product Type Item Code (Source) NDC:58394-016

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58394-016-03 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 SYRINGE 4 mL Part 2 2 PACKET 2 mL

Part 1 of 2 XYNTHA antihemophilic factor (recombinant) injection, powder, lyophilized, for solution

Product Information Item Code (Source) NDC:58394-116 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MOROCTOCOG ALFA (MOROCTOCOG ALFA) MOROCTOCOG ALFA 3000 [iU] in 4 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.036 mg in 4 mL SUCROSE HISTIDINE CALCIUM CHLORIDE POLYSORBATE 80 WATER 4 mL in 4 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58394-116-03 4 mL in 1 SYRINGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125264 08/13/2010

Part 2 of 2 ALCOHOL alcohol swab

Product Information Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 1 mL in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 08/13/2010

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125264 08/13/2010

Labeler — Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC (174350868)

Establishment
Name	Address	ID/FEI	Operations
Wyeth Farma SA		462005232	ANALYSIS (58394-016), ANALYSIS (58394-022), ANALYSIS (58394-023), ANALYSIS (58394-024), ANALYSIS (58394-025), MANUFACTURE (58394-016), MANUFACTURE (58394-022), MANUFACTURE (58394-023), MANUFACTURE (58394-024), MANUFACTURE (58394-025), PACK (58394-016), PACK (58394-022), PACK (58394-023), PACK (58394-024), PACK (58394-025), LABEL (58394-016), LABEL (58394-022), LABEL (58394-023), LABEL (58394-024), LABEL (58394-025)

Revised: 03/2023 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC