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 useInitial U.S. Approval: 2001
Approved
Approval ID
4b65f642-87f7-4da5-a9c9-02cd1f8d9d16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 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 Code67457-585
Application NumberNDA021345
Marketing CategoryC73605
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
fondaparinux sodium
PRODUCT DETAILS
NDC Product Code67457-583
Application NumberNDA021345
Marketing CategoryC73605
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2020
Generic Namefondaparinux sodium
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FONDAPARINUX SODIUMActive
Quantity: 5 mg in 0.4 mL
Code: X0Q6N9USOZ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
fondaparinux sodium
PRODUCT DETAILS
NDC Product Code67457-584
Application NumberNDA021345
Marketing CategoryC73605
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2020
Generic Namefondaparinux sodium
INGREDIENTS (5)
FONDAPARINUX SODIUMActive
Quantity: 7.5 mg in 0.6 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 Code67457-582
Application NumberNDA021345
Marketing CategoryC73605
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2020
Generic Namefondaparinux sodium
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FONDAPARINUX SODIUMActive
Quantity: 2.5 mg in 0.5 mL
Code: X0Q6N9USOZ
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM