FDA.reportPublic FDA data

Fondaparinux Sodium

Product NDC
55111-678
11-digit product format
551110678
Labeler code
55111
Product ID
55111-678_2a3f9c6b-885b-843d-9cc8-3eb67395fbda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fondaparinux Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA091316
Marketing category
ANDA
Marketing start
2011-07-14
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
55111-678-02Fondaparinux Sodium2 in 1 CARTONINJECTION216
55111-678-10Fondaparinux Sodium10 in 1 CARTONINJECTION1016
55111-678-11Fondaparinux Sodium0.5 mL in 1 SYRINGEINJECTION0.516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-678-02ML - Milliliter55111-678085d2a3d-a9f3-4e5e-8a4d-b06737e6acce12012-07-24
55111-678-10ML - Milliliter55111-678327694e9-cf74-4833-bf9e-d92f897d6f7a12012-07-24
55111-678-11ML - Milliliter55111-6789599c744-d30e-4751-8019-2dae5e91588612015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fondaparinux sodiumACTIVE INGREDIENTX0Q6N9USOZFONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES LIMITED]10
fondaparinuxACTIVE MOIETYJ177FOW5JLFONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES LIMITED]10
hydrochloric acidINACTIVE INGREDIENTQTT17582CBFONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES LIMITED]10
sodium chlorideINACTIVE INGREDIENT451W47IQ8XFONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES LIMITED]10
sodium hydroxideINACTIVE INGREDIENT55X04QC32IFONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES LIMITED]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-678FONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES LIMITED]16Current NDC, Legacy NDC, 3 package rows20210911_49e0d7bc-3f49-849b-c77c-98682d1c0d19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861356fondaparinux sodium 10 MG in 0.8 ML Prefilled SyringePSN49e0d7bc-3f49-849b-c77c-98682d1c0d1916
861360fondaparinux sodium 2.5 MG in 0.5 ML Prefilled SyringePSN49e0d7bc-3f49-849b-c77c-98682d1c0d1916
861363fondaparinux sodium 5 MG in 0.4 ML Prefilled SyringePSN49e0d7bc-3f49-849b-c77c-98682d1c0d1916
861365fondaparinux sodium 7.5 MG in 0.6 ML Prefilled SyringePSN49e0d7bc-3f49-849b-c77c-98682d1c0d1916
8613630.4 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCD49e0d7bc-3f49-849b-c77c-98682d1c0d1916
8613600.5 ML fondaparinux sodium 5 MG/ML Prefilled SyringeSCD49e0d7bc-3f49-849b-c77c-98682d1c0d1916
8613650.6 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCD49e0d7bc-3f49-849b-c77c-98682d1c0d1916
8613560.8 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCD49e0d7bc-3f49-849b-c77c-98682d1c0d1916
861356fondaparinux sodium 10 MG per 0.8 ML Prefilled SyringeSY49e0d7bc-3f49-849b-c77c-98682d1c0d1916
861360fondaparinux sodium 2.5 MG per 0.5 ML Prefilled SyringeSY49e0d7bc-3f49-849b-c77c-98682d1c0d1916
861363fondaparinux sodium 5 MG per 0.4 ML Prefilled SyringeSY49e0d7bc-3f49-849b-c77c-98682d1c0d1916
861365fondaparinux sodium 7.5 MG per 0.6 ML Prefilled SyringeSY49e0d7bc-3f49-849b-c77c-98682d1c0d1916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-678-02551110678022 SYRINGE in 1 CARTON (55111-678-02) / .5 mL in 1 SYRINGE (55111-678-11) 2 syringe2011-07-140000-00-00NoNoCurrent
55111-678-105511106781010 SYRINGE in 1 CARTON (55111-678-10) / .5 mL in 1 SYRINGE (55111-678-11) 10 syringe2011-07-140000-00-00NoNoCurrent
55111-678-11551110678110.5 mL in 1 SYRINGE0.5 mlHistorical