Heparin Sodium

Manufacturing Establishments (1)

Fresenius Kabi USA, LLC

Labeler

Fresenius Kabi USA, LLC

DUNS Number

840771732

Products (8)

NDC Product Code

63323-540

Application Number

NDA017029

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

February 18, 2020

Ingredients

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACTQuantity: 0.15 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

HeparinActive

Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL

Heparin Sodium

NDC Product Code

63323-047

Application Number

NDA017651

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

February 18, 2020

Ingredients

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACTQuantity: 15 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 6 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

HeparinActive

Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 1 mL

Heparin Sodium

NDC Product Code

63323-543

Application Number

NDA017029

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

February 18, 2020

Ingredients

HeparinActive

Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 0.5 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

Heparin Sodium

NDC Product Code

63323-262

Application Number

NDA017029

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

February 18, 2020

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 5 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACTQuantity: 0.15 mg in 1 mL

HeparinActive

Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 1 mL

Heparin Sodium

NDC Product Code

63323-542

Application Number

NDA017029

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

February 18, 2020

Ingredients

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACTQuantity: 0.15 mg in 1 mL

HeparinActive

Code: ZZ45AB24CAClass: ACTIMQuantity: 10000 [USP'U] in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Heparin Sodium

NDC Product Code

63323-915

Application Number

NDA017029

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

February 18, 2020

Ingredients

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

HeparinActive

Code: ZZ45AB24CAClass: ACTIMQuantity: 20000 [USP'U] in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACTQuantity: 0.15 mg in 1 mL

Heparin Sodium

NDC Product Code

63323-276

Application Number

NDA017029

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

February 18, 2020

Ingredients

HeparinActive

Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Heparin Sodium

NDC Product Code

63323-459

Application Number

NDA017029

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

February 18, 2020

Ingredients

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACTQuantity: 10.42 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 5 mg in 1 mL

HeparinActive

Code: ZZ45AB24CAClass: ACTIMQuantity: 10000 [USP'U] in 1 mL

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Heparin Sodium

Manufacturing Establishments (1)

Products (8)

Heparin Sodium

Heparin Sodium

Heparin Sodium

Heparin Sodium

Heparin Sodium

Heparin Sodium

Heparin Sodium

Heparin Sodium