Fondaparinux Sodium
These highlights do not include all the information needed to use FONDAPARINUX SODIUM INJECTION safely and effectively. See full prescribing information for FONDAPARINUX SODIUM INJECTION. Initial U.S. Approval: 2001
Approved
Approval ID
49e0d7bc-3f49-849b-c77c-98682d1c0d19
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 10, 2021
Manufacturers
FDA
Dr. Reddy's Laboratories Limited
DUNS: 650562841
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fondaparinux Sodium
PRODUCT DETAILS
NDC Product Code55111-678
Application NumberANDA091316
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 18, 2018
Generic NameFondaparinux Sodium
INGREDIENTS (4)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
fondaparinux sodiumActive
Quantity: 2.5 mg in 0.5 mL
Code: X0Q6N9USOZ
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Fondaparinux Sodium
PRODUCT DETAILS
NDC Product Code55111-679
Application NumberANDA091316
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 18, 2018
Generic NameFondaparinux Sodium
INGREDIENTS (4)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
fondaparinux sodiumActive
Quantity: 5 mg in 0.4 mL
Code: X0Q6N9USOZ
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Fondaparinux Sodium
PRODUCT DETAILS
NDC Product Code55111-680
Application NumberANDA091316
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 18, 2018
Generic NameFondaparinux Sodium
INGREDIENTS (4)
fondaparinux sodiumActive
Quantity: 7.5 mg in 0.6 mL
Code: X0Q6N9USOZ
Classification: ACTIB
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Fondaparinux Sodium
PRODUCT DETAILS
NDC Product Code55111-681
Application NumberANDA091316
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 18, 2018
Generic NameFondaparinux Sodium
INGREDIENTS (4)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
fondaparinux sodiumActive
Quantity: 10 mg in 0.8 mL
Code: X0Q6N9USOZ
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT