NDC 43598-609

Fondaparinux Sodium

Fondaparinux Sodium

Fondaparinux Sodium is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddy's Laboratories Inc.. The primary component is Fondaparinux Sodium.

• Product ID: 43598-609_744da4b5-af8a-7df3-a643-d27c95617ddc
• NDC: 43598-609
• Product Type: Human Prescription Drug
• Proprietary Name: Fondaparinux Sodium
• Generic Name: Fondaparinux Sodium
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-07-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091316
• Labeler Name: Dr. Reddy's Laboratories 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: 2020-12-31

Packaging

NDC 43598-609-02

2 SYRINGE in 1 CARTON (43598-609-02) > .6 mL in 1 SYRINGE (43598-609-11)

• Marketing Start Date: 2017-07-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43598-609-10 [43598060910]

Fondaparinux Sodium INJECTION

• Marketing Category: ANDA
• Application Number: ANDA091316
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-07-27

NDC 43598-609-11 [43598060911]

Fondaparinux Sodium INJECTION

• Marketing Category: ANDA
• Application Number: ANDA091316
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-07-27

NDC 43598-609-02 [43598060902]

Fondaparinux Sodium INJECTION

• Marketing Category: ANDA
• Application Number: ANDA091316
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-07-27

Drug Details

Active Ingredients

Ingredient	Strength
FONDAPARINUX SODIUM	7.5 mg/.6mL

OpenFDA Data

• SPL SET ID: 8a27f341-f612-de72-8c1f-3fd977905de0
• Manufacturer:
  • Dr. Reddy's Laboratories 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