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
baa50757-a927-4d56-a933-5d7798fe6ab0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2021
Manufacturers
FDA
Sandoz Inc.
DUNS: 005387188
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-3454
Application NumberANDA206812
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fondaparinux Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 16, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
FONDAPARINUX SODIUMActive
Quantity: 5 mg in 0.4 mL
Code: X0Q6N9USOZ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Fondaparinux Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-3443
Application NumberANDA206812
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fondaparinux Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 16, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
FONDAPARINUX SODIUMActive
Quantity: 2.5 mg in 0.5 mL
Code: X0Q6N9USOZ
Classification: ACTIB
Fondaparinux Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-3476
Application NumberANDA206812
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fondaparinux Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 16, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
FONDAPARINUX SODIUMActive
Quantity: 10 mg in 0.8 mL
Code: X0Q6N9USOZ
Classification: ACTIB
Fondaparinux Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-3465
Application NumberANDA206812
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fondaparinux Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 16, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FONDAPARINUX SODIUMActive
Quantity: 7.5 mg in 0.6 mL
Code: X0Q6N9USOZ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT