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
8a27f341-f612-de72-8c1f-3fd977905de0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2022
Manufacturers
FDA
Dr. Reddy's Laboratories Inc.
DUNS: 802315887
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 Code43598-607
Application NumberANDA091316
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 23, 2022
Generic NameFondaparinux Sodium
INGREDIENTS (4)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
fondaparinux sodiumActive
Quantity: 2.5 mg in 0.5 mL
Code: X0Q6N9USOZ
Classification: ACTIB
Fondaparinux Sodium
PRODUCT DETAILS
NDC Product Code43598-608
Application NumberANDA091316
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 23, 2022
Generic NameFondaparinux Sodium
INGREDIENTS (4)
fondaparinux sodiumActive
Quantity: 5 mg in 0.4 mL
Code: X0Q6N9USOZ
Classification: ACTIB
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Fondaparinux Sodium
PRODUCT DETAILS
NDC Product Code43598-606
Application NumberANDA091316
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 23, 2022
Generic NameFondaparinux Sodium
INGREDIENTS (4)
fondaparinux sodiumActive
Quantity: 10 mg in 0.8 mL
Code: X0Q6N9USOZ
Classification: ACTIB
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Fondaparinux Sodium
PRODUCT DETAILS
NDC Product Code43598-609
Application NumberANDA091316
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 23, 2022
Generic NameFondaparinux Sodium
INGREDIENTS (4)
fondaparinux sodiumActive
Quantity: 7.5 mg in 0.6 mL
Code: X0Q6N9USOZ
Classification: ACTIB
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT