NDC 70710-1516

fondaparinux sodium

Fondaparinux Sodium

fondaparinux sodium is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Fondaparinux Sodium.

• Product ID: 70710-1516_c6101d68-f81e-4336-9d9b-9aedf49a6603
• NDC: 70710-1516
• Product Type: Human Prescription Drug
• Proprietary Name: fondaparinux sodium
• Generic Name: Fondaparinux Sodium
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-02-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208615
• Labeler Name: Zydus Pharmaceuticals (USA) Inc.
• Substance Name: FONDAPARINUX SODIUM
• Active Ingredient Strength: 8 mg/.6mL
• Pharm Classes: Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70710-1516-6

10 SYRINGE in 1 CARTON (70710-1516-6) > .6 mL in 1 SYRINGE (70710-1516-2)

• Marketing Start Date: 2019-02-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70710-1516-6 [70710151606]

fondaparinux sodium INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA208615
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-02-06

NDC 70710-1516-9 [70710151609]

fondaparinux sodium INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA208615
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-02-06

NDC 70710-1516-2 [70710151602]

fondaparinux sodium INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA208615
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-02-06

Drug Details

Active Ingredients

Ingredient	Strength
FONDAPARINUX SODIUM	7.5 mg/.6mL

OpenFDA Data

• SPL SET ID: dffbf7c9-495e-4a33-ac76-57b52f014fc2
• Manufacturer:
  • Zydus Pharmaceuticals (USA) Inc.
• UNII:
  • X0Q6N9USOZ
• RxNorm Concept Unique ID - RxCUI:
  • 861356
  • 861365
  • 861363
  • 861360

Pharmacological Class

• 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