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.FONDAPARINUX SODIUM injection, for subcutaneous use Initial U.S. Approval: 2001
Approved
Approval ID
dffbf7c9-495e-4a33-ac76-57b52f014fc2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2020
Manufacturers
FDA
Zydus Pharmaceuticals (USA) Inc.
DUNS: 156861945
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 Code70710-1514
Application NumberANDA208615
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2018
Generic Namefondaparinux sodium
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
fondaparinux sodiumActive
Quantity: 2.5 mg in 0.5 mL
Code: X0Q6N9USOZ
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
fondaparinux sodium
PRODUCT DETAILS
NDC Product Code70710-1516
Application NumberANDA208615
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2018
Generic Namefondaparinux sodium
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
fondaparinux sodiumActive
Quantity: 7.5 mg in 0.6 mL
Code: X0Q6N9USOZ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
fondaparinux sodium
PRODUCT DETAILS
NDC Product Code70710-1517
Application NumberANDA208615
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2018
Generic Namefondaparinux sodium
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
fondaparinux sodiumActive
Quantity: 10 mg in 0.8 mL
Code: X0Q6N9USOZ
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
fondaparinux sodium
PRODUCT DETAILS
NDC Product Code70710-1515
Application NumberANDA208615
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2018
Generic Namefondaparinux sodium
INGREDIENTS (5)
fondaparinux sodiumActive
Quantity: 5 mg in 0.4 mL
Code: X0Q6N9USOZ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT