NDC Code(s) : 0007-3230-01, 0007-3230-02, 0007-3230-11, 0007-3230-61, 0007-3232-11, 0007-3234-01, 0007-3234-02, 0007-3234-11, 0007-3234-61, 0007-3236-01, 0007-3236-02, 0007-3236-11
Packager : GlaxoSmithKline LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ARIXTRAfondaparinux sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0007-3230
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FONDAPARINUX SODIUM(UNII: X0Q6N9USOZ)
(FONDAPARINUX - UNII:J177FOW5JL) 		FONDAPARINUX SODIUM2.5 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW (clear and colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0007-3230-022 in 1 CARTON 30/03/2005
1NDC:0007-3230-010.5 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0007-3230-1110 in 1 CARTON 30/03/2005
20.5 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0007-3230-612 in 1 CARTON 30/03/2005
30.5 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021345 03/30/2005 10/31/2016
ARIXTRAfondaparinux sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0007-3232
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FONDAPARINUX SODIUM(UNII: X0Q6N9USOZ)
(FONDAPARINUX - UNII:J177FOW5JL) 		FONDAPARINUX SODIUM5 mg in 0.4 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW (clear and colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0007-3232-1110 in 1 CARTON 17/11/2004
10.4 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021345 11/17/2004 11/30/2016
ARIXTRAfondaparinux sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0007-3234
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FONDAPARINUX SODIUM(UNII: X0Q6N9USOZ)
(FONDAPARINUX - UNII:J177FOW5JL) 		FONDAPARINUX SODIUM7.5 mg in 0.6 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW (clear and colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0007-3234-022 in 1 CARTON 17/11/2004
1NDC:0007-3234-010.6 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0007-3234-1110 in 1 CARTON 17/11/2004
20.6 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0007-3234-612 in 1 CARTON 17/11/2004
30.6 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021345 11/17/2004 11/30/2016
ARIXTRAfondaparinux sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0007-3236
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FONDAPARINUX SODIUM(UNII: X0Q6N9USOZ)
(FONDAPARINUX - UNII:J177FOW5JL) 		FONDAPARINUX SODIUM10 mg in 0.8 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW (clear and colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0007-3236-022 in 1 CARTON 17/11/2004
1NDC:0007-3236-010.8 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0007-3236-1110 in 1 CARTON 17/11/2004
20.8 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021345 11/17/2004 09/30/2016

PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 0007-3230-02

Arixtra®

(fondaparinux sodium) Injection

2.5 mg/0.5 mL

2 x 0.5 mL

Contains 2 Single Dose, Prefilled Syringes

Rx only

Single Dose, Prefilled Syringes

Affixed with an Automatic Needle Protection System

For Subcutaneous Injection

Contents: Each single dose prefilled syringe contains 2.5 mg of fondaparinux sodium in 0.5 mL of an isotonic solution of sodium chloride and water for injection.

The needle guard of the prefilled syringe of ARIXTRA contains dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.

Recommended Dose: 2.5 mg subcutaneous injection, once daily. See package insert.

Storage: Store at 25oC (77oF); excursions permitted to 15oC – 30oC (59oF -86oF), (see USP Controlled Room Temperature).

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in France

©2008, GlaxoSmithKline

Rev. 6/08

11000000002826

Arixtra 2.5 mg/0.5 mL carton

PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 0007-3232-11

Arixtra®

(fondaparinux sodium) Injection

5 mg/0.4 mL

10 x 0.4 mL

Contains 10 Single Dose, Prefilled Syringes

Single Dose, Prefilled Syringes

Affixed with an Automatic Needle Protection System

For Subcutaneous Injection

Rx only

Made in France

©2011, GlaxoSmithKline

Rev. 8/11

11000000008395

Arixtra 5 mg 10 count carton

PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 0007-3234-11

Arixtra®

(fondaparinux sodium) Injection

7.5 mg/0.6 mL

10 x 0.6 mL

Contains 10 Single Dose, Prefilled Syringes

Single Dose, Prefilled Syringes

Affixed with an Automatic Needle Protection System

For Subcutaneous Injection

Rx only

Made in France

©2011, GlaxoSmithKline

Rev. 8/11

11000000008394

Arixtra 7.5 mg 10 count carton

PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 0007-3236-11

Arixtra®

(fondaparinux sodium) Injection

10 mg/0.8 mL

10 x 0.8 mL

Contains 10 Single Dose, Prefilled Syringes

Single Dose, Prefilled Syringes

Affixed with an Automatic Needle Protection System

For Subcutaneous Injection

Rx only

Made in France

©2011, GlaxoSmithKline

Rev. 2/11

11000000007790

Arixtra 10 mg 10 count carton