FDA.reportPublic FDA data

fondaparinux sodium

Product NDC
70710-1515
11-digit product format
707101515
Labeler code
70710
Product ID
70710-1515_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
5 mg/.4mL
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 SODIUM5 mg/.4mL

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
70710-1515-2fondaparinux sodium0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.420
70710-1515-6fondaparinux sodium10 in 1 CARTONINJECTION, SOLUTION1020
70710-1515-9fondaparinux sodium2 in 1 CARTONINJECTION, SOLUTION220

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1515-2ML - Milliliter70710-15157f4cd7be-4209-48e2-bf67-3b8a57c0d54512020-02-13
70710-1515-6ML - Milliliter70710-151525dd227e-53a4-4cf3-9641-ab268904c3e012020-02-13
70710-1515-9ML - Milliliter70710-15159045b096-3601-48f0-bf28-e9e98742af5812020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1515FONDAPARINUX 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
70710-1515-2707101515020.4 mL in 1 SYRINGE0.4 mlHistorical
70710-1515-67071015150610 SYRINGE in 1 CARTON (70710-1515-6) / .4 mL in 1 SYRINGE (70710-1515-2) 10 syringe2019-02-060000-00-00NoNoCurrent
70710-1515-9707101515092 SYRINGE in 1 CARTON (70710-1515-9) / .4 mL in 1 SYRINGE (70710-1515-2) 2 syringe2019-02-060000-00-00NoNoCurrent