FDA.reportPublic FDA data

fondaparinux sodium

Product NDC
70710-1516
11-digit product format
707101516
Labeler code
70710
Product ID
70710-1516_4234bd9e-7f61-2cb0-e063-6294a90a4e14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fondaparinux sodium
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA208615
Marketing category
ANDA
Marketing start
2019-02-06
Substance
FONDAPARINUX SODIUM
Active strength
7.5 mg/.6mL
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 SODIUM7.5 mg/.6mL

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
70710-1516-2fondaparinux sodium0.6 mL in 1 SYRINGEINJECTION, SOLUTION0.620
70710-1516-6fondaparinux sodium10 in 1 CARTONINJECTION, SOLUTION1020
70710-1516-9fondaparinux sodium2 in 1 CARTONINJECTION, SOLUTION220

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1516-2ML - Milliliter70710-15162885df0f-9311-4b24-b27b-3234412f96eb12020-02-13
70710-1516-6ML - Milliliter70710-15165eb95a77-6bc5-498f-b573-b401ac307ec512020-02-13
70710-1516-9ML - Milliliter70710-15168b6539bc-7d17-4b20-8569-91b3f1b2675412020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1516FONDAPARINUX SODIUM INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS (USA) INC.]10Current NDC, Legacy NDC, 3 package rows20241106_dffbf7c9-495e-4a33-ac76-57b52f014fc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861356fondaparinux sodium 10 MG in 0.8 ML Prefilled SyringePSNdffbf7c9-495e-4a33-ac76-57b52f014fc220
861360fondaparinux sodium 2.5 MG in 0.5 ML Prefilled SyringePSNdffbf7c9-495e-4a33-ac76-57b52f014fc220
861363fondaparinux sodium 5 MG in 0.4 ML Prefilled SyringePSNdffbf7c9-495e-4a33-ac76-57b52f014fc220
861365fondaparinux sodium 7.5 MG in 0.6 ML Prefilled SyringePSNdffbf7c9-495e-4a33-ac76-57b52f014fc220
8613630.4 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCDdffbf7c9-495e-4a33-ac76-57b52f014fc220
8613600.5 ML fondaparinux sodium 5 MG/ML Prefilled SyringeSCDdffbf7c9-495e-4a33-ac76-57b52f014fc220
8613650.6 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCDdffbf7c9-495e-4a33-ac76-57b52f014fc220
8613560.8 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCDdffbf7c9-495e-4a33-ac76-57b52f014fc220
861356fondaparinux sodium 10 MG per 0.8 ML Prefilled SyringeSYdffbf7c9-495e-4a33-ac76-57b52f014fc220
861360fondaparinux sodium 2.5 MG per 0.5 ML Prefilled SyringeSYdffbf7c9-495e-4a33-ac76-57b52f014fc220
861363fondaparinux sodium 5 MG per 0.4 ML Prefilled SyringeSYdffbf7c9-495e-4a33-ac76-57b52f014fc220
861365fondaparinux sodium 7.5 MG per 0.6 ML Prefilled SyringeSYdffbf7c9-495e-4a33-ac76-57b52f014fc220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1516-2707101516020.6 mL in 1 SYRINGE0.6 mlHistorical
70710-1516-67071015160610 SYRINGE in 1 CARTON (70710-1516-6) / .6 mL in 1 SYRINGE (70710-1516-2) 10 syringe2019-02-060000-00-00NoNoCurrent
70710-1516-9707101516092 SYRINGE in 1 CARTON (70710-1516-9) / .6 mL in 1 SYRINGE (70710-1516-2) 2 syringe2019-02-060000-00-00NoNoCurrent