arixtra

Generic: fondaparinux sodium

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

Drug Facts

Product Profile

Brand Name arixtra
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 67457-592
Product ID 67457-592_8de301f7-88ad-41d7-9ec3-884cab56f943
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021345
Listing Expiration 2026-12-31
Marketing Start 2014-05-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457592
Hyphenated Format 67457-592

Supplemental Identifiers

RxCUI
861356 861358 861360 861362 861363 861364 861365 861366
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 arixtra (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 (67457-592-10) / .5 mL in 1 SYRINGE, GLASS (67457-592-00)
source: ndc

Packages (1)

67457-592-10 10 SYRINGE, GLASS in 1 CARTON (67457-592-10) / .5 mL in 1 SYRINGE, GLASS (67457-592-00)

Ingredients (1)

fondaparinux sodium (2.5 mg/.5mL)

Linked Drug Pages (1)

Arixtra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "8de301f7-88ad-41d7-9ec3-884cab56f943", "openfda": {"unii": ["X0Q6N9USOZ"], "rxcui": ["861356", "861358", "861360", "861362", "861363", "861364", "861365", "861366"], "spl_set_id": ["d3b30c68-cf45-4b46-8ba6-72090f7ba01a"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE, GLASS in 1 CARTON (67457-592-10)  / .5 mL in 1 SYRINGE, GLASS (67457-592-00)", "package_ndc": "67457-592-10", "marketing_start_date": "20140519"}], "brand_name": "Arixtra", "product_id": "67457-592_8de301f7-88ad-41d7-9ec3-884cab56f943", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "67457-592", "generic_name": "fondaparinux sodium", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Arixtra", "active_ingredients": [{"name": "FONDAPARINUX SODIUM", "strength": "2.5 mg/.5mL"}], "application_number": "NDA021345", "marketing_category": "NDA", "marketing_start_date": "20140519", "listing_expiration_date": "20261231"}