Fondaparinux Sodium (Page 13 of 13)

PRINCIPAL DISPLAY PANEL – 2.5 mg/0.5 mL

NDC 67457-582-10

Fondaparinux Sodium
Injection, USP

2.5 mg/0.5 mL

For Subcutaneous Injection

PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient.

Rx only

Contains 10 Single-Dose, Prefilled Syringes
Affixed with an Automatic Needle Protection System

Contents: Each single-dose prefilled syringe contains 2.5 mg of fondaparinux sodium, USP in 0.5 mL of an isotonic solution of sodium chloride and water for injection. May also contain sodium hydroxide and/or hydrochloric acid as pH adjusters.

The needle guard of the prefilled syringe of Fondaparinux Sodium Injection 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 20° to 25°C (68° to 77°F); excursions permitted 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature].

Discard unused portion.

Manufactured for:
Mylan Institutional LLC Morgantown, WV 26505 U.S.A.

Made in France

MI:582:10C:R6

Fondaparinux Sodium Injection, USP 2.5 mg/0.5 mL Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 5 mg/0.4 mL

NDC 67457-583-04

Fondaparinux Sodium Injection, USP

5 mg/0.4 mL

For Subcutaneous Injection

PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient.

Rx only

Contains 10 Single-Dose, Prefilled Syringes
Affixed with an Automatic Needle Protection System

Contents: Each single-dose prefilled syringe contains 5 mg of fondaparinux sodium, USP in 0.4 mL of an isotonic solution of sodium chloride and water for injection. May also contain sodium hydroxide and/or hydrochloric acid as pH adjusters.

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

Recommended Dose: 5 mg subcutaneous injection, once daily. See package insert.

Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature].

Discard unused portion.

Manufactured for:
Mylan Institutional LLC Morgantown, WV 26505 U.S.A.

Made in France

MI:583:10C:R6

Fondaparinux Sodium Injection, USP 5 mg/0.4 mL Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 7.5 mg/0.6 mL

NDC 67457-584-06

Fondaparinux Sodium Injection, USP

7.5 mg/0.6 mL

For Subcutaneous Injection

PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient.

Rx only

Contains 10 Single-Dose, Prefilled Syringes
Affixed with an Automatic Needle Protection System

Contents: Each single-dose prefilled syringe contains 7.5 mg of fondaparinux sodium, USP in 0.6 mL of an isotonic solution of sodium chloride and water for injection. May also contain sodium hydroxide and/or hydrochloric acid as pH adjusters.

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

Recommended Dose: 7.5 mg subcutaneous injection, once daily. See package insert.

Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature].

Discard unused portion.

Manufactured for:
Mylan Institutional LLC Morgantown, WV 26505 U.S.A.

Made in France

MI:584:10C:R6

Fondaparinux Sodium Injection, USP 7.5 mg/0.6 mL Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 10 mg/0.8 mL

NDC 67457-585-08

Fondaparinux Sodium Injection, USP

10 mg/0.8 mL

For Subcutaneous Injection

PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient.

Rx only

Contains 10 Single-Dose, Prefilled Syringes
Affixed with an Automatic Needle Protection System

Contents: Each single-dose prefilled syringe contains 10 mg of fondaparinux sodium, USP in 0.8 mL of an isotonic solution of sodium chloride and water for injection. May also contain sodium hydroxide and/or hydrochloric acid as pH adjusters.

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

Recommended Dose: 10 mg subcutaneous injection, once daily. See package insert.

Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature].

Discard unused portion.

Manufactured for:
Mylan Institutional LLC Morgantown, WV 26505 U.S.A.

Made in France

MI:585:10C:R6

Fondaparinux Sodium Injection, USP 10 mg/0.8 mL Carton Label
(click image for full-size original)
FONDAPARINUX SODIUM fondaparinux sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-582
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FONDAPARINUX SODIUM (FONDAPARINUX) FONDAPARINUX SODIUM 2.5 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Product Characteristics
Color YELLOW (clear and colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-582-10 10 SYRINGE in 1 CARTON contains a SYRINGE (67457-582-00)
1 NDC:67457-582-00 0.5 mL in 1 SYRINGE This package is contained within the CARTON (67457-582-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021345 01/05/2015
FONDAPARINUX SODIUM fondaparinux sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-583
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FONDAPARINUX SODIUM (FONDAPARINUX) FONDAPARINUX SODIUM 5 mg in 0.4 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Product Characteristics
Color YELLOW (clear and colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-583-04 10 SYRINGE in 1 CARTON contains a SYRINGE (67457-583-00)
1 NDC:67457-583-00 0.4 mL in 1 SYRINGE This package is contained within the CARTON (67457-583-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021345 01/05/2015
FONDAPARINUX SODIUM fondaparinux sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-584
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FONDAPARINUX SODIUM (FONDAPARINUX) FONDAPARINUX SODIUM 7.5 mg in 0.6 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Product Characteristics
Color YELLOW (clear and colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-584-06 10 SYRINGE in 1 CARTON contains a SYRINGE (67457-584-00)
1 NDC:67457-584-00 0.6 mL in 1 SYRINGE This package is contained within the CARTON (67457-584-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021345 01/05/2015
FONDAPARINUX SODIUM fondaparinux sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-585
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FONDAPARINUX SODIUM (FONDAPARINUX) FONDAPARINUX SODIUM 10 mg in 0.8 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Product Characteristics
Color YELLOW (clear and colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-585-08 10 SYRINGE in 1 CARTON contains a SYRINGE (67457-585-00)
1 NDC:67457-585-00 0.8 mL in 1 SYRINGE This package is contained within the CARTON (67457-585-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021345 01/05/2015
Labeler — Mylan Institutional LLC (790384502)

Revised: 08/2020 Mylan Institutional LLC

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