CEPROTIN: Package Insert and Label Information (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 10 mL Vial Label — NDC 52919-005-05

10 mL

NDC 52919-005-05

Shire

Sterile Water for Injection, USP
for reconstitution of accompanying product

Do not use unless clear. No antimicrobial agent or other substance has been
added. Do not use for intravascular injection without making approximately
isotonic by addition of suitable solute. Discard unused portion. Rx Only

Single-Dose Container

Nonpyrogenic 0742615

PRINCIPAL DISPLAY PANEL -- 10 mL Vial Label -- NDC 52919-005-05
(click image for full-size original)
CEPROTIN protein c concentrate human kit
Product Information
Product Type Item Code (Source) NDC:0944-4177
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0944-4177-05 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 5 mL
Part 2 1 VIAL, GLASS 5 mL
Part 1 of 2
CEPROTIN protein c concentrate human injection, powder, lyophilized, for solution
Product Information
Item Code (Source) NDC:0944-4176
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROTEIN C (PROTEIN C) PROTEIN C 500 [iU] in 5 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN
TRISODIUM CITRATE DIHYDRATE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0944-4176-01 5 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125234 08/09/2010
Part 2 of 2
STERILE WATER water liquid
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER 5 mL in 5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 5 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125234 08/09/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125234 08/09/2010
CEPROTIN protein c concentrate human kit
Product Information
Product Type Item Code (Source) NDC:0944-4179
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0944-4179-10 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 10 mL
Part 2 1 VIAL, GLASS 10 mL
Part 1 of 2
CEPROTIN protein c concentrate human injection, powder, lyophilized, for solution
Product Information
Item Code (Source) NDC:0944-4178
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROTEIN C (PROTEIN C) PROTEIN C 1000 [iU] in 10 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN
TRISODIUM CITRATE DIHYDRATE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0944-4178-02 10 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125234 08/09/2010
Part 2 of 2
STERILE WATER water liquid
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER 10 mL in 10 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 10 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125234 08/09/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125234 08/09/2010
Labeler — Baxalta US Inc. (079887619)
Establishment
Name Address ID/FEI Operations
Baxter Aktiengesellschaft 300434670 MANUFACTURE (0944-4177), MANUFACTURE (0944-4179)

Revised: 09/2021 Baxalta US Inc.

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