fondaparinux sodium

Generic: fondaparinux sodium

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name fondaparinux sodium
Generic Name fondaparinux sodium
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

fondaparinux sodium 2.5 mg/.5mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-582
Product ID 67457-582_40824645-13d9-4302-9b37-fcc3dc64b4a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021345
Listing Expiration 2026-12-31
Marketing Start 2015-01-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457582
Hyphenated Format 67457-582

Supplemental Identifiers

RxCUI
861356 861360 861363 861365
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 NDA021345 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/.5mL
source: ndc
Packaging
  • 10 SYRINGE, GLASS in 1 CARTON (67457-582-10) / .5 mL in 1 SYRINGE, GLASS (67457-582-00)
source: ndc

Packages (1)

67457-582-10 10 SYRINGE, GLASS in 1 CARTON (67457-582-10) / .5 mL in 1 SYRINGE, GLASS (67457-582-00)

Ingredients (1)

fondaparinux sodium (2.5 mg/.5mL)

Linked Drug Pages (1)

Fondaparinux Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "40824645-13d9-4302-9b37-fcc3dc64b4a6", "openfda": {"unii": ["X0Q6N9USOZ"], "rxcui": ["861356", "861360", "861363", "861365"], "spl_set_id": ["4b65f642-87f7-4da5-a9c9-02cd1f8d9d16"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE, GLASS in 1 CARTON (67457-582-10)  / .5 mL in 1 SYRINGE, GLASS (67457-582-00)", "package_ndc": "67457-582-10", "marketing_start_date": "20150105"}], "brand_name": "Fondaparinux Sodium", "product_id": "67457-582_40824645-13d9-4302-9b37-fcc3dc64b4a6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "67457-582", "generic_name": "fondaparinux sodium", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fondaparinux Sodium", "active_ingredients": [{"name": "FONDAPARINUX SODIUM", "strength": "2.5 mg/.5mL"}], "application_number": "NDA021345", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20150105", "listing_expiration_date": "20261231"}