FDA.reportPublic FDA data

FONDAPARINUX SODIUM

Product NDC
55150-230
11-digit product format
551500230
Labeler code
55150
Product ID
55150-230_a193830a-dc25-412a-b047-d2fa77d9dbbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FONDAPARINUX SODIUM
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eugia US LLC
Application
ANDA206918
Marketing category
ANDA
Marketing start
2017-12-26
Substance
FONDAPARINUX SODIUM
Active strength
2.5 mg/.5mL
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 SODIUM2.5 mg/.5mL

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
55150-230-00FONDAPARINUX SODIUM0.5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.55
55150-230-02FONDAPARINUX SODIUM2 in 1 CARTONINJECTION, SOLUTION25
55150-230-10FONDAPARINUX SODIUM10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-230-00ML - Milliliter55150-230faabb381-165b-4e1a-8609-b666df3b322012018-02-20
55150-230-10ML - Milliliter55150-230da5b7c9c-e4a5-4a8d-82c7-51ada0e6b2cf12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-230FONDAPARINUX SODIUM INJECTION, SOLUTION [EUGIA US LLC]5Current NDC, Legacy NDC, 3 package rows20240206_8ea61d0d-4403-4d9f-a946-85a459cc0aa0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861356fondaparinux sodium 10 MG in 0.8 ML Prefilled SyringePSN8ea61d0d-4403-4d9f-a946-85a459cc0aa05
861360fondaparinux sodium 2.5 MG in 0.5 ML Prefilled SyringePSN8ea61d0d-4403-4d9f-a946-85a459cc0aa05
861363fondaparinux sodium 5 MG in 0.4 ML Prefilled SyringePSN8ea61d0d-4403-4d9f-a946-85a459cc0aa05
861365fondaparinux sodium 7.5 MG in 0.6 ML Prefilled SyringePSN8ea61d0d-4403-4d9f-a946-85a459cc0aa05
8613630.4 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCD8ea61d0d-4403-4d9f-a946-85a459cc0aa05
8613600.5 ML fondaparinux sodium 5 MG/ML Prefilled SyringeSCD8ea61d0d-4403-4d9f-a946-85a459cc0aa05
8613650.6 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCD8ea61d0d-4403-4d9f-a946-85a459cc0aa05
8613560.8 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCD8ea61d0d-4403-4d9f-a946-85a459cc0aa05
861356fondaparinux sodium 10 MG per 0.8 ML Prefilled SyringeSY8ea61d0d-4403-4d9f-a946-85a459cc0aa05
861360fondaparinux sodium 2.5 MG per 0.5 ML Prefilled SyringeSY8ea61d0d-4403-4d9f-a946-85a459cc0aa05
861363fondaparinux sodium 5 MG per 0.4 ML Prefilled SyringeSY8ea61d0d-4403-4d9f-a946-85a459cc0aa05
861365fondaparinux sodium 7.5 MG per 0.6 ML Prefilled SyringeSY8ea61d0d-4403-4d9f-a946-85a459cc0aa05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-230-00551500230000.5 mL in 1 SYRINGE, GLASS0.5 mlHistorical
55150-230-02551500230022 SYRINGE, GLASS in 1 CARTON (55150-230-02) / .5 mL in 1 SYRINGE, GLASS (55150-230-00) 2017-12-260000-00-00NoNoCurrent
55150-230-105515002301010 SYRINGE, GLASS in 1 CARTON (55150-230-10) / .5 mL in 1 SYRINGE, GLASS (55150-230-00) 2017-12-260000-00-00NoNoCurrent