fondaparinux sodium

Generic: fondaparinux sodium

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fondaparinux sodium
Generic Name fondaparinux sodium
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

fondaparinux sodium 5 mg/.4mL

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 70710-1515
Product ID 70710-1515_4234bd9e-7f61-2cb0-e063-6294a90a4e14
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208615
Listing Expiration 2026-12-31
Marketing Start 2019-02-06

Pharmacologic Class

Classes
factor xa inhibitor [epc] factor xa inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101515
Hyphenated Format 70710-1515

Supplemental Identifiers

RxCUI
861356 861360 861363 861365
UPC
0370710151799 0370710151492 0370710151768 0370710151690 0370710151461 0370710151591 0370710151669 0370710151560
UNII
X0Q6N9USOZ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fondaparinux sodium (source: ndc)
Generic Name fondaparinux sodium (source: ndc)
Application Number ANDA208615 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/.4mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (70710-1515-6) / .4 mL in 1 SYRINGE (70710-1515-2)
  • 2 SYRINGE in 1 CARTON (70710-1515-9) / .4 mL in 1 SYRINGE (70710-1515-2)
source: ndc

Packages (2)

70710-1515-6 10 SYRINGE in 1 CARTON (70710-1515-6) / .4 mL in 1 SYRINGE (70710-1515-2) 70710-1515-9 2 SYRINGE in 1 CARTON (70710-1515-9) / .4 mL in 1 SYRINGE (70710-1515-2)

Ingredients (1)

fondaparinux sodium (5 mg/.4mL)

Linked Drug Pages (1)

fondaparinux sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "4234bd9e-7f61-2cb0-e063-6294a90a4e14", "openfda": {"upc": ["0370710151799", "0370710151492", "0370710151768", "0370710151690", "0370710151461", "0370710151591", "0370710151669", "0370710151560"], "unii": ["X0Q6N9USOZ"], "rxcui": ["861356", "861360", "861363", "861365"], "spl_set_id": ["dffbf7c9-495e-4a33-ac76-57b52f014fc2"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (70710-1515-6)  / .4 mL in 1 SYRINGE (70710-1515-2)", "package_ndc": "70710-1515-6", "marketing_start_date": "20190206"}, {"sample": false, "description": "2 SYRINGE in 1 CARTON (70710-1515-9)  / .4 mL in 1 SYRINGE (70710-1515-2)", "package_ndc": "70710-1515-9", "marketing_start_date": "20190206"}], "brand_name": "fondaparinux sodium", "product_id": "70710-1515_4234bd9e-7f61-2cb0-e063-6294a90a4e14", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "70710-1515", "generic_name": "fondaparinux sodium", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fondaparinux sodium", "active_ingredients": [{"name": "FONDAPARINUX SODIUM", "strength": "5 mg/.4mL"}], "application_number": "ANDA208615", "marketing_category": "ANDA", "marketing_start_date": "20190206", "listing_expiration_date": "20261231"}