fondaparinux sodium

Generic: fondaparinux sodium

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fondaparinux sodium 10 mg/.8mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-233
Product ID 55150-233_a193830a-dc25-412a-b047-d2fa77d9dbbc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206918
Listing Expiration 2026-12-31
Marketing Start 2017-12-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150233
Hyphenated Format 55150-233

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 ANDA206918 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/.8mL
source: ndc
Packaging
  • 2 SYRINGE, GLASS in 1 CARTON (55150-233-02) / .8 mL in 1 SYRINGE, GLASS (55150-233-00)
  • 10 SYRINGE, GLASS in 1 CARTON (55150-233-10) / .8 mL in 1 SYRINGE, GLASS (55150-233-00)
source: ndc

Packages (2)

55150-233-02 2 SYRINGE, GLASS in 1 CARTON (55150-233-02) / .8 mL in 1 SYRINGE, GLASS (55150-233-00) 55150-233-10 10 SYRINGE, GLASS in 1 CARTON (55150-233-10) / .8 mL in 1 SYRINGE, GLASS (55150-233-00)

Ingredients (1)

fondaparinux sodium (10 mg/.8mL)

Linked Drug Pages (1)

FONDAPARINUX SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "a193830a-dc25-412a-b047-d2fa77d9dbbc", "openfda": {"unii": ["X0Q6N9USOZ"], "rxcui": ["861356", "861360", "861363", "861365"], "spl_set_id": ["8ea61d0d-4403-4d9f-a946-85a459cc0aa0"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (55150-233-02)  / .8 mL in 1 SYRINGE, GLASS (55150-233-00)", "package_ndc": "55150-233-02", "marketing_start_date": "20171226"}, {"sample": false, "description": "10 SYRINGE, GLASS in 1 CARTON (55150-233-10)  / .8 mL in 1 SYRINGE, GLASS (55150-233-00)", "package_ndc": "55150-233-10", "marketing_start_date": "20171226"}], "brand_name": "FONDAPARINUX SODIUM", "product_id": "55150-233_a193830a-dc25-412a-b047-d2fa77d9dbbc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "55150-233", "generic_name": "FONDAPARINUX SODIUM", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FONDAPARINUX SODIUM", "active_ingredients": [{"name": "FONDAPARINUX SODIUM", "strength": "10 mg/.8mL"}], "application_number": "ANDA206918", "marketing_category": "ANDA", "marketing_start_date": "20171226", "listing_expiration_date": "20261231"}