fondaparinux sodium

Generic: fondaparinux sodium

Labeler: italfarmaco s.p.a
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fondaparinux sodium
Generic Name fondaparinux sodium
Labeler italfarmaco s.p.a
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

fondaparinux sodium 10 mg/.8mL

Manufacturer
Italfarmaco S.p.A

Identifiers & Regulatory

Product NDC 11797-157
Product ID 11797-157_714aaf0c-95ac-4de9-b8d2-5fdcd1365804
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 11797157
Hyphenated Format 11797-157

Supplemental Identifiers

RxCUI
861356 861360 861363 861365
UPC
0311797154068 0311797154099 0311797156062 0311797155096 0311797156093 0311797157069 0311797157090 0311797155065
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
  • 10 mg/.8mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (11797-157-06) / .8 mL in 1 SYRINGE (11797-157-02)
  • 2 SYRINGE in 1 CARTON (11797-157-09) / .8 mL in 1 SYRINGE (11797-157-02)
source: ndc

Packages (2)

11797-157-06 10 SYRINGE in 1 CARTON (11797-157-06) / .8 mL in 1 SYRINGE (11797-157-02) 11797-157-09 2 SYRINGE in 1 CARTON (11797-157-09) / .8 mL in 1 SYRINGE (11797-157-02)

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": "714aaf0c-95ac-4de9-b8d2-5fdcd1365804", "openfda": {"upc": ["0311797154068", "0311797154099", "0311797156062", "0311797155096", "0311797156093", "0311797157069", "0311797157090", "0311797155065"], "unii": ["X0Q6N9USOZ"], "rxcui": ["861356", "861360", "861363", "861365"], "spl_set_id": ["58789e3d-e5bc-4c2e-a527-495a252fcecd"], "manufacturer_name": ["Italfarmaco S.p.A"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (11797-157-06)  / .8 mL in 1 SYRINGE (11797-157-02)", "package_ndc": "11797-157-06", "marketing_start_date": "20190206"}, {"sample": false, "description": "2 SYRINGE in 1 CARTON (11797-157-09)  / .8 mL in 1 SYRINGE (11797-157-02)", "package_ndc": "11797-157-09", "marketing_start_date": "20190206"}], "brand_name": "fondaparinux sodium", "product_id": "11797-157_714aaf0c-95ac-4de9-b8d2-5fdcd1365804", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "11797-157", "generic_name": "fondaparinux sodium", "labeler_name": "Italfarmaco S.p.A", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fondaparinux sodium", "active_ingredients": [{"name": "FONDAPARINUX SODIUM", "strength": "10 mg/.8mL"}], "application_number": "ANDA208615", "marketing_category": "ANDA", "marketing_start_date": "20190206", "listing_expiration_date": "20261231"}