Arixtra
These highlights do not include all the information needed to use ARIXTRA safely and effectively. See full prescribing information for ARIXTRA. ARIXTRA (fondaparinux sodium injection), for subcutaneous useInitial U.S. Approval: 2001
Approved
Approval ID
d3b30c68-cf45-4b46-8ba6-72090f7ba01a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 20, 2020
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-594
Application NumberNDA021345
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateJune 8, 2020
Generic Namefondaparinux sodium
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
FONDAPARINUX SODIUMActive
Quantity: 7.5 mg in 0.6 mL
Code: X0Q6N9USOZ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
fondaparinux sodium
PRODUCT DETAILS
NDC Product Code67457-595
Application NumberNDA021345
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateJune 8, 2020
Generic Namefondaparinux sodium
INGREDIENTS (5)
FONDAPARINUX SODIUMActive
Quantity: 10 mg in 0.8 mL
Code: X0Q6N9USOZ
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
fondaparinux sodium
PRODUCT DETAILS
NDC Product Code67457-593
Application NumberNDA021345
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateJune 8, 2020
Generic Namefondaparinux sodium
INGREDIENTS (5)
FONDAPARINUX SODIUMActive
Quantity: 5 mg in 0.4 mL
Code: X0Q6N9USOZ
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
fondaparinux sodium
PRODUCT DETAILS
NDC Product Code67457-592
Application NumberNDA021345
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateJune 8, 2020
Generic Namefondaparinux sodium
INGREDIENTS (5)
FONDAPARINUX SODIUMActive
Quantity: 2.5 mg in 0.5 mL
Code: X0Q6N9USOZ
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM