FDA.reportPublic FDA data

Fondaparinux Sodium

Product NDC
0781-3476
11-digit product format
007813476
Labeler code
0781
Product ID
0781-3476_3d5a4b69-462b-7e51-e063-6294a90a0721
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fondaparinux Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Sandoz Inc.
Application
ANDA206812
Marketing category
ANDA
Marketing start
2019-06-18
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
Fondaparinux Sodium
Listing expiration
2026-12-31

Active Ingredients#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-3476-122021-08-03C16284748780-1c7ccaba7-11c4-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use FONDAPARINUX SODIUM INJECTION safely and effectively. See full prescribing information for FONDAPARINUX SODIUM INJECTION. FONDAPARINUX SODIUM injection, for subcutaneous use Initial U.S. Approval: 2001
0781-3476-952021-08-03C16284748780-1c7ccaba7-11c4-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use FONDAPARINUX SODIUM INJECTION safely and effectively. See full prescribing information for FONDAPARINUX SODIUM INJECTION. FONDAPARINUX SODIUM injection, for subcutaneous use Initial U.S. Approval: 2001
0781-3476-122021-07-23C16284748780-1c7ccaba7-11c4-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use FONDAPARINUX SODIUM INJECTION safely and effectively. See full prescribing information for FONDAPARINUX SODIUM INJECTION. FONDAPARINUX SODIUM injection, for subcutaneous use Initial U.S. Approval: 2001
0781-3476-952021-07-23C16284748780-1c7ccaba7-11c4-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use FONDAPARINUX SODIUM INJECTION safely and effectively. See full prescribing information for FONDAPARINUX SODIUM INJECTION. FONDAPARINUX SODIUM injection, for subcutaneous use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3476-12Fondaparinux Sodium2 in 1 CARTONINJECTION218
0781-3476-94Fondaparinux Sodium0.8 mL in 1 SYRINGEINJECTION0.818
0781-3476-95Fondaparinux Sodium10 in 1 CARTONINJECTION1018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3476FONDAPARINUX SODIUM INJECTION [SANDOZ INC.]17Current NDC, Legacy NDC, 3 package rows20250302_baa50757-a927-4d56-a933-5d7798fe6ab0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861356fondaparinux sodium 10 MG in 0.8 ML Prefilled SyringePSNbaa50757-a927-4d56-a933-5d7798fe6ab018
861360fondaparinux sodium 2.5 MG in 0.5 ML Prefilled SyringePSNbaa50757-a927-4d56-a933-5d7798fe6ab018
861363fondaparinux sodium 5 MG in 0.4 ML Prefilled SyringePSNbaa50757-a927-4d56-a933-5d7798fe6ab018
861365fondaparinux sodium 7.5 MG in 0.6 ML Prefilled SyringePSNbaa50757-a927-4d56-a933-5d7798fe6ab018
8613630.4 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCDbaa50757-a927-4d56-a933-5d7798fe6ab018
8613600.5 ML fondaparinux sodium 5 MG/ML Prefilled SyringeSCDbaa50757-a927-4d56-a933-5d7798fe6ab018
8613650.6 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCDbaa50757-a927-4d56-a933-5d7798fe6ab018
8613560.8 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCDbaa50757-a927-4d56-a933-5d7798fe6ab018
861356fondaparinux sodium 10 MG per 0.8 ML Prefilled SyringeSYbaa50757-a927-4d56-a933-5d7798fe6ab018
861360fondaparinux sodium 2.5 MG per 0.5 ML Prefilled SyringeSYbaa50757-a927-4d56-a933-5d7798fe6ab018
861363fondaparinux sodium 5 MG per 0.4 ML Prefilled SyringeSYbaa50757-a927-4d56-a933-5d7798fe6ab018
861365fondaparinux sodium 7.5 MG per 0.6 ML Prefilled SyringeSYbaa50757-a927-4d56-a933-5d7798fe6ab018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3476-12007813476122 SYRINGE in 1 CARTON (0781-3476-12) / .8 mL in 1 SYRINGE (0781-3476-94) 2 syringe2019-06-180000-00-00NoNoCurrent
0781-3476-94007813476940.8 mL in 1 SYRINGE0.8 mlHistorical
0781-3476-950078134769510 SYRINGE in 1 CARTON (0781-3476-95) / .8 mL in 1 SYRINGE (0781-3476-94) 10 syringe2019-06-180000-00-00NoNoCurrent