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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

58789e3d-e5bc-4c2e-a527-495a252fcecd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 30, 2020

Manufacturers
FDA

Italfarmaco S.p.A

DUNS: 428179329

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 Code11797-157
Application NumberANDA208615
Product Classification
M
Marketing Category
C73584
G
Generic Name
fondaparinux sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 21, 2019
FDA Product Classification

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: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

fondaparinux sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11797-154
Application NumberANDA208615
Product Classification
M
Marketing Category
C73584
G
Generic Name
fondaparinux sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 21, 2019
FDA Product Classification

INGREDIENTS (5)

WATERInactive
Code: 059QF0KO0R
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
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

fondaparinux sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11797-155
Application NumberANDA208615
Product Classification
M
Marketing Category
C73584
G
Generic Name
fondaparinux sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 21, 2019
FDA Product Classification

INGREDIENTS (5)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
fondaparinux sodiumActive
Quantity: 5 mg in 0.4 mL
Code: X0Q6N9USOZ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

fondaparinux sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11797-156
Application NumberANDA208615
Product Classification
M
Marketing Category
C73584
G
Generic Name
fondaparinux sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 21, 2019
FDA Product Classification

INGREDIENTS (5)

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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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fondaparinux sodium - FDA Drug Approval Details