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) Solution for subcutaneous injection Initial U.S. Approval: 2001
Approved
Approval ID
ec235119-cb58-4939-942c-11d3923d289f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fondaparinux sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5652
Application NumberNDA021345
Product Classification
M
Marketing Category
C73594
G
Generic Name
fondaparinux sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 23, 2012
FDA Product Classification
INGREDIENTS (3)
FONDAPARINUX SODIUMActive
Quantity: 5 mg in 0.4 mL
Code: X0Q6N9USOZ
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
fondaparinux sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5501
Application NumberNDA021345
Product Classification
M
Marketing Category
C73594
G
Generic Name
fondaparinux sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 23, 2012
FDA Product Classification
INGREDIENTS (3)
FONDAPARINUX SODIUMActive
Quantity: 7.5 mg in 0.6 mL
Code: X0Q6N9USOZ
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT