NDC Code(s) : 64193-223-02, 64193-224-02, 64193-225-02
Packager : Baxter Healthcare Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FEIBA Anti-Inhibitor Coagulant Complex KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64193-223
Route of Administration DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64193-223-021 in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101447 01/31/1986
FEIBA Anti-Inhibitor Coagulant Complex KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64193-224
Route of Administration DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64193-224-021 in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101447 01/31/1986
FEIBA Anti-Inhibitor Coagulant Complex KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64193-225
Route of Administration DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64193-225-021 in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101447 01/31/1986

PRINCIPAL DISPLAY PANEL

FEIBA NF 500U vial labelFEIBA NF 500U vial label

20 mL size, dried

NDC 64193-323-01

Anti-Inhibitor Coagulant Complex

FEIBA NF

Nanofiltered & Vapor Heated

Baxter

For Intravenous Use Only

Contains no preservative

Dosage & Administration: See accompanying package insert

Storage: Store at room temperature not to exceed 25°C (77°F).

Reconstitution: Use 20 mL sWFI, U.S.P.; Keep at room temperature not to exceed 25°C (77°F); Use within 3 hours of reconstitution

Rx only

FEIBA NF 500U vial labelFEIBA NF 500U unit carton

20 mL size, dried

NDC 64193-223-02

Anti-Inhibitor Coagulant Complex

FEIBA NF

Nanofiltered & Vapor Heated

Baxter

For Intravenous Use Only

Contains no preservative

Dosage & Administration: See accompanying package insert

Storage: Store at room temperature not to exceed 25°C (77°F). Store in the original package in order to protect from light.

Reconstitution: Use 20 mL sWFI, U.S.P.; Keep at room temperature not to exceed 25°C (77°F); Use within 3 hours of reconstitution

Do Not Freeze

Rx only

Includes BAXJECT Needleless Transfer Device

FEIBA NF 500U vial label20 mL Sterile Water for Injection

1A7141

NDC 0338-0764-02

20 mL Single-Dose Container Nonpyrogenic

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. This Product Contains Dry Natural Rubber.

Baxter

Manufactured by

Baxter Healthcare Corporation

Deerfield, IL 60015 USA