FDA.reportPublic FDA data

Fondaparinux Sodium

Product NDC
67457-583
11-digit product format
674570583
Labeler code
67457
Product ID
67457-583_40824645-13d9-4302-9b37-fcc3dc64b4a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fondaparinux sodium
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Mylan Institutional LLC
Application
NDA021345
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-01-05
Substance
FONDAPARINUX SODIUM
Active strength
5 mg/.4mL
Pharmacologic classes
Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fondaparinux Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FONDAPARINUX SODIUM5 mg/.4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX0Q6N9USOZ
Rxcui861356, 861360, 861363, 861365

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
03ac78a4-5655-4d9a-b2f1-a0919f833364Product name520250818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-583-00Fondaparinux Sodium0.4 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.411
67457-583-04Fondaparinux Sodium10 in 1 CARTONINJECTION, SOLUTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-583-00ML - Milliliter67457-583eb426f89-8310-41da-88fd-b250ff65232912015-01-05
67457-583-04ML - Milliliter67457-5832db969d3-3e8e-4ad3-a04c-3ef9b664938c12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FONDAPARINUX SODIUMACTIVE INGREDIENTX0Q6N9USOZFONDAPARINUX SODIUM INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
FONDAPARINUXACTIVE MOIETYJ177FOW5JLFONDAPARINUX SODIUM INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFONDAPARINUX SODIUM INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RFONDAPARINUX SODIUM INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-583FONDAPARINUX SODIUM INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]11Current NDC, Legacy NDC, 2 package rows20250212_4b65f642-87f7-4da5-a9c9-02cd1f8d9d16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861356fondaparinux sodium 10 MG in 0.8 ML Prefilled SyringePSN4b65f642-87f7-4da5-a9c9-02cd1f8d9d1611
861360fondaparinux sodium 2.5 MG in 0.5 ML Prefilled SyringePSN4b65f642-87f7-4da5-a9c9-02cd1f8d9d1611
861363fondaparinux sodium 5 MG in 0.4 ML Prefilled SyringePSN4b65f642-87f7-4da5-a9c9-02cd1f8d9d1611
861365fondaparinux sodium 7.5 MG in 0.6 ML Prefilled SyringePSN4b65f642-87f7-4da5-a9c9-02cd1f8d9d1611
8613630.4 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCD4b65f642-87f7-4da5-a9c9-02cd1f8d9d1611
8613600.5 ML fondaparinux sodium 5 MG/ML Prefilled SyringeSCD4b65f642-87f7-4da5-a9c9-02cd1f8d9d1611
8613650.6 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCD4b65f642-87f7-4da5-a9c9-02cd1f8d9d1611
8613560.8 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCD4b65f642-87f7-4da5-a9c9-02cd1f8d9d1611
861356fondaparinux sodium 10 MG per 0.8 ML Prefilled SyringeSY4b65f642-87f7-4da5-a9c9-02cd1f8d9d1611
861360fondaparinux sodium 2.5 MG per 0.5 ML Prefilled SyringeSY4b65f642-87f7-4da5-a9c9-02cd1f8d9d1611
861363fondaparinux sodium 5 MG per 0.4 ML Prefilled SyringeSY4b65f642-87f7-4da5-a9c9-02cd1f8d9d1611
861365fondaparinux sodium 7.5 MG per 0.6 ML Prefilled SyringeSY4b65f642-87f7-4da5-a9c9-02cd1f8d9d1611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-583-00674570583000.4 mL in 1 SYRINGE, GLASS0.4 mlHistorical
67457-583-046745705830410 SYRINGE, GLASS in 1 CARTON (67457-583-04) / .4 mL in 1 SYRINGE, GLASS (67457-583-00) 2015-01-050000-00-00NoNoCurrent