NDC 0781-3443

Fondaparinux Sodium

Fondaparinux Sodium

Fondaparinux Sodium is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc.. The primary component is Fondaparinux Sodium.

• Product ID: 0781-3443_7882a340-8edb-312c-e053-2991aa0a855d
• NDC: 0781-3443
• Product Type: Human Prescription Drug
• Proprietary Name: Fondaparinux Sodium
• Generic Name: Fondaparinux Sodium
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-06-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206812
• Labeler Name: Sandoz Inc.
• Substance Name: FONDAPARINUX SODIUM
• Active Ingredient Strength: 3 mg/.5mL
• Pharm Classes: Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0781-3443-12

2 SYRINGE in 1 CARTON (0781-3443-12) > .5 mL in 1 SYRINGE (0781-3443-94)

• Marketing Start Date: 2019-06-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-3443-94 [00781344394]

Fondaparinux Sodium INJECTION

• Marketing Category: ANDA
• Application Number: ANDA206812
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-18

NDC 0781-3443-12 [00781344312]

Fondaparinux Sodium INJECTION

• Marketing Category: ANDA
• Application Number: ANDA206812
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-18

NDC 0781-3443-95 [00781344395]

Fondaparinux Sodium INJECTION

• Marketing Category: ANDA
• Application Number: ANDA206812
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-18

Drug Details

Active Ingredients

Ingredient	Strength
FONDAPARINUX SODIUM	2.5 mg/.5mL

OpenFDA Data

• SPL SET ID: baa50757-a927-4d56-a933-5d7798fe6ab0
• Manufacturer:
  • Sandoz 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