fondaparinux sodium

Generic: fondaparinux sodium

Labeler: sandoz inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fondaparinux sodium
Generic Name fondaparinux sodium
Labeler sandoz inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

fondaparinux sodium 5 mg/.4mL

Manufacturer
Sandoz Inc.

Identifiers & Regulatory

Product NDC 0781-3454
Product ID 0781-3454_3d5a4b69-462b-7e51-e063-6294a90a0721
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206812
Listing Expiration 2026-12-31
Marketing Start 2019-06-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813454
Hyphenated Format 0781-3454

Supplemental Identifiers

RxCUI
861356 861360 861363 861365
UPC
0307813465126 0307813476955 0307813476122 0307813465959
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 ANDA206812 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/.4mL
source: ndc
Packaging
  • 2 SYRINGE in 1 CARTON (0781-3454-12) / .4 mL in 1 SYRINGE (0781-3454-94)
  • 10 SYRINGE in 1 CARTON (0781-3454-95) / .4 mL in 1 SYRINGE (0781-3454-94)
source: ndc

Packages (2)

0781-3454-12 2 SYRINGE in 1 CARTON (0781-3454-12) / .4 mL in 1 SYRINGE (0781-3454-94) 0781-3454-95 10 SYRINGE in 1 CARTON (0781-3454-95) / .4 mL in 1 SYRINGE (0781-3454-94)

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": "3d5a4b69-462b-7e51-e063-6294a90a0721", "openfda": {"upc": ["0307813465126", "0307813476955", "0307813476122", "0307813465959"], "unii": ["X0Q6N9USOZ"], "rxcui": ["861356", "861360", "861363", "861365"], "spl_set_id": ["baa50757-a927-4d56-a933-5d7798fe6ab0"], "manufacturer_name": ["Sandoz Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE in 1 CARTON (0781-3454-12)  / .4 mL in 1 SYRINGE (0781-3454-94)", "package_ndc": "0781-3454-12", "marketing_start_date": "20190618"}, {"sample": false, "description": "10 SYRINGE in 1 CARTON (0781-3454-95)  / .4 mL in 1 SYRINGE (0781-3454-94)", "package_ndc": "0781-3454-95", "marketing_start_date": "20190618"}], "brand_name": "Fondaparinux Sodium", "product_id": "0781-3454_3d5a4b69-462b-7e51-e063-6294a90a0721", "dosage_form": "INJECTION", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "0781-3454", "generic_name": "Fondaparinux Sodium", "labeler_name": "Sandoz Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fondaparinux Sodium", "active_ingredients": [{"name": "FONDAPARINUX SODIUM", "strength": "5 mg/.4mL"}], "application_number": "ANDA206812", "marketing_category": "ANDA", "marketing_start_date": "20190618", "listing_expiration_date": "20261231"}