FDA.reportPublic FDA data

Arixtra

Product NDC
67457-595
11-digit product format
674570595
Labeler code
67457
Product ID
67457-595_8de301f7-88ad-41d7-9ec3-884cab56f943
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fondaparinux sodium
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Mylan Institutional LLC
Application
NDA021345
Marketing category
NDA
Marketing start
2014-05-19
Substance
FONDAPARINUX SODIUM
Active strength
10 mg/.8mL
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
Arixtra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FONDAPARINUX SODIUM10 mg/.8mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX0Q6N9USOZ
Rxcui861356, 861358, 861360, 861362, 861363, 861364, 861365, 861366

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
67457-595-00Arixtra0.8 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.813
67457-595-08Arixtra10 in 1 CARTONINJECTION, SOLUTION1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-595-00ML - Milliliter67457-5954f10aab8-4852-423e-a64d-ffc3b14bb6d812015-12-02
67457-595-08ML - Milliliter67457-5957f32e5f4-44ff-43d7-acff-6178c7887f9f12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FONDAPARINUX SODIUMACTIVE INGREDIENTX0Q6N9USOZARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]2
FONDAPARINUXACTIVE MOIETYJ177FOW5JLARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-595ARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]13Current NDC, Legacy NDC, 2 package rows20250201_d3b30c68-cf45-4b46-8ba6-72090f7ba01a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861358Arixtra 10 MG in 0.8 ML Prefilled SyringePSNd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861366Arixtra 7.5 MG in 0.6 ML Prefilled SyringePSNd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861362Atrixtra 2.5 MG in 0.5 ML Prefilled SyringePSNd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861364Atrixtra 5 MG in 0.4 ML Prefilled SyringePSNd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861356fondaparinux sodium 10 MG in 0.8 ML Prefilled SyringePSNd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861360fondaparinux sodium 2.5 MG in 0.5 ML Prefilled SyringePSNd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861363fondaparinux sodium 5 MG in 0.4 ML Prefilled SyringePSNd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861365fondaparinux sodium 7.5 MG in 0.6 ML Prefilled SyringePSNd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
8613640.4 ML fondaparinux sodium 12.5 MG/ML Prefilled Syringe [Arixtra]SBDd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
8613620.5 ML fondaparinux sodium 5 MG/ML Prefilled Syringe [Arixtra]SBDd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
8613660.6 ML fondaparinux sodium 12.5 MG/ML Prefilled Syringe [Arixtra]SBDd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
8613580.8 ML fondaparinux sodium 12.5 MG/ML Prefilled Syringe [Arixtra]SBDd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
8613630.4 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCDd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
8613600.5 ML fondaparinux sodium 5 MG/ML Prefilled SyringeSCDd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
8613650.6 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCDd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
8613560.8 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCDd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
8613640.4 ML Arixtra 12.5 MG/ML Prefilled SyringeSYd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
8613620.5 ML Arixtra 5 MG/ML Prefilled SyringeSYd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
8613660.6 ML Arixtra 12.5 MG/ML Prefilled SyringeSYd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
8613580.8 ML Arixtra 12.5 MG/ML Prefilled SyringeSYd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861358Arixtra 10 MG per 0.8 ML Prefilled SyringeSYd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861366Arixtra 7.5 MG per 0.6 ML Prefilled SyringeSYd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861362Atrixtra 2.5 MG per 0.5 ML Prefilled SyringeSYd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861364Atrixtra 5 MG per 0.4 ML Prefilled SyringeSYd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861356fondaparinux sodium 10 MG per 0.8 ML Prefilled SyringeSYd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861360fondaparinux sodium 2.5 MG per 0.5 ML Prefilled SyringeSYd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861363fondaparinux sodium 5 MG per 0.4 ML Prefilled SyringeSYd3b30c68-cf45-4b46-8ba6-72090f7ba01a13
861365fondaparinux sodium 7.5 MG per 0.6 ML Prefilled SyringeSYd3b30c68-cf45-4b46-8ba6-72090f7ba01a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-595-00674570595000.8 mL in 1 SYRINGE, GLASS0.8 mlHistorical
67457-595-086745705950810 SYRINGE, GLASS in 1 CARTON (67457-595-08) / .8 mL in 1 SYRINGE, GLASS (67457-595-00) 2014-05-190000-00-00NoNoCurrent