NDC 67457-595

Arixtra

Fondaparinux Sodium

Arixtra is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Fondaparinux Sodium.

• Product ID: 67457-595_348fba8c-8c70-48da-b0d6-15c3f2b995c3
• NDC: 67457-595
• Product Type: Human Prescription Drug
• Proprietary Name: Arixtra
• Generic Name: Fondaparinux Sodium
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2015-11-13
• Marketing Category: NDA / NDA
• Application Number: NDA021345
• Labeler Name: Mylan Institutional LLC
• Substance Name: FONDAPARINUX SODIUM
• Active Ingredient Strength: 10 mg/.8mL
• Pharm Classes: Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 67457-595-08

10 SYRINGE, PLASTIC in 1 CARTON (67457-595-08) > .8 mL in 1 SYRINGE, PLASTIC (67457-595-00)

• Marketing Start Date: 2015-11-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-595-00 [67457059500]

Arixtra INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021345
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-11-13

NDC 67457-595-08 [67457059508]

Arixtra INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021345
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-11-13

NDC 67457-595-02 [67457059502]

Arixtra INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021345
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-11-13
• Marketing End Date: 2015-08-18

Drug Details

Active Ingredients

Ingredient	Strength
FONDAPARINUX SODIUM	10 mg/.8mL

OpenFDA Data

• SPL SET ID: d3b30c68-cf45-4b46-8ba6-72090f7ba01a
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • X0Q6N9USOZ
• RxNorm Concept Unique ID - RxCUI:
  • 861366
  • 861364
  • 861365
  • 861362
  • 861363
  • 861360
  • 861358
  • 861356

Pharmacological Class

• Factor Xa Inhibitor [EPC]
• Factor Xa Inhibitors [MoA]

NDC Crossover Matching brand name "Arixtra" or generic name "Fondaparinux Sodium"

NDC	Brand Name	Generic Name
67457-592	Arixtra	Arixtra
67457-593	Arixtra	Arixtra
67457-594	Arixtra	Arixtra
67457-595	Arixtra	Arixtra
0781-3443	Fondaparinux Sodium	Fondaparinux Sodium
0781-3454	Fondaparinux Sodium	Fondaparinux Sodium
0781-3465	Fondaparinux Sodium	Fondaparinux Sodium
0781-3476	Fondaparinux Sodium	Fondaparinux Sodium
11797-154	fondaparinux sodium	fondaparinux sodium
11797-155	fondaparinux sodium	fondaparinux sodium
11797-156	fondaparinux sodium	fondaparinux sodium
11797-157	fondaparinux sodium	fondaparinux sodium
43598-606	Fondaparinux Sodium	Fondaparinux Sodium
43598-607	Fondaparinux Sodium	Fondaparinux Sodium
43598-608	Fondaparinux Sodium	Fondaparinux Sodium
43598-609	Fondaparinux Sodium	Fondaparinux Sodium