NDC 67457-583

Fondaparinux Sodium

Fondaparinux Sodium

Fondaparinux Sodium 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: 67457-583_09da1394-44bc-42dc-a911-4a664881efa9
• NDC: 67457-583
• Product Type: Human Prescription Drug
• Proprietary Name: Fondaparinux Sodium
• Generic Name: Fondaparinux Sodium
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2015-01-05
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA021345
• Labeler Name: Mylan Institutional LLC
• Substance Name: FONDAPARINUX SODIUM
• Active Ingredient Strength: 5 mg/.4mL
• Pharm Classes: Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 67457-583-04

10 SYRINGE in 1 CARTON (67457-583-04) > .4 mL in 1 SYRINGE (67457-583-00)

• Marketing Start Date: 2015-01-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-583-00 [67457058300]

Fondaparinux Sodium INJECTION, SOLUTION

• Marketing Category: NDA authorized generic
• Application Number: NDA021345
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-01-05

NDC 67457-583-02 [67457058302]

Fondaparinux Sodium INJECTION, SOLUTION

• Marketing Category: NDA authorized generic
• Application Number: NDA021345
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-01-05
• Marketing End Date: 2015-01-07

NDC 67457-583-04 [67457058304]

Fondaparinux Sodium INJECTION, SOLUTION

• Marketing Category: NDA authorized generic
• Application Number: NDA021345
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-01-05

Drug Details

Active Ingredients

Ingredient	Strength
FONDAPARINUX SODIUM	5 mg/.4mL

OpenFDA Data

• SPL SET ID: 4b65f642-87f7-4da5-a9c9-02cd1f8d9d16
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • X0Q6N9USOZ
• RxNorm Concept Unique ID - RxCUI:
  • 861356
  • 861365
  • 861363
  • 861360

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
70710-1515	fondaparinux sodium	fondaparinux sodium
70710-1514	fondaparinux sodium	fondaparinux sodium
70710-1517	fondaparinux sodium	fondaparinux sodium
70710-1516	fondaparinux sodium	fondaparinux sodium
55111-681	Fondaparinux Sodium	Fondaparinux Sodium
55111-678	Fondaparinux Sodium	Fondaparinux Sodium
55150-231	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM
55150-232	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM
55150-230	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM
55111-679	Fondaparinux Sodium	Fondaparinux Sodium
55111-680	Fondaparinux Sodium	Fondaparinux Sodium
55150-233	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM
67457-582	Fondaparinux Sodium	Fondaparinux Sodium
67457-583	Fondaparinux Sodium	Fondaparinux Sodium
67457-584	Fondaparinux Sodium	Fondaparinux Sodium
67457-585	Fondaparinux Sodium	Fondaparinux Sodium