NDC 11797-157

fondaparinux sodium

Fondaparinux Sodium

fondaparinux sodium is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Italfarmaco S.p.a. The primary component is Fondaparinux Sodium.

• Product ID: 11797-157_39ad9bc7-5c3d-4d74-8d6f-873971520356
• NDC: 11797-157
• 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: Italfarmaco S.p.A
• 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 11797-157-06

10 SYRINGE in 1 CARTON (11797-157-06) > .8 mL in 1 SYRINGE (11797-157-02)

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

NDC SPL Data Element Entries

NDC 11797-157-02 [11797015702]

fondaparinux sodium INJECTION, SOLUTION

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

NDC 11797-157-09 [11797015709]

fondaparinux sodium INJECTION, SOLUTION

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

NDC 11797-157-06 [11797015706]

fondaparinux sodium INJECTION, SOLUTION

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

Drug Details

Active Ingredients

Ingredient	Strength
FONDAPARINUX SODIUM	10 mg/.8mL

OpenFDA Data

• SPL SET ID: 58789e3d-e5bc-4c2e-a527-495a252fcecd
• Manufacturer:
  • Italfarmaco S.p.A
• UNII:
  • X0Q6N9USOZ
• RxNorm Concept Unique ID - RxCUI:
  • 861356
  • 861365
  • 861363
  • 861360
• UPC Code:
  • 0311797157090
  • 0311797155065
  • 0311797157069
  • 0311797156093
  • 0311797154068
  • 0311797156062
  • 0311797154099
  • 0311797155096

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