Heparin Sodium
Heparin Sodium Injection USP
Approved
Approval ID
d55b4a63-0c04-4874-b74f-9e9b9e8b008c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 18, 2020
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 8
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HEPARIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-540
Application NumberNDA017029
Product Classification
M
Marketing Category
C73594
G
Generic Name
HEPARIN SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 18, 2020
FDA Product Classification
INGREDIENTS (6)
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HEPARIN SODIUMActive
Quantity: 1000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
HEPARIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-047
Application NumberNDA017651
Product Classification
M
Marketing Category
C73594
G
Generic Name
HEPARIN SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 18, 2020
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 15 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HEPARIN SODIUMActive
Quantity: 5000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
HEPARIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-543
Application NumberNDA017029
Product Classification
M
Marketing Category
C73594
G
Generic Name
HEPARIN SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 18, 2020
FDA Product Classification
INGREDIENTS (3)
HEPARIN SODIUMActive
Quantity: 5000 [USP'U] in 0.5 mL
Code: ZZ45AB24CA
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HEPARIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-262
Application NumberNDA017029
Product Classification
M
Marketing Category
C73594
G
Generic Name
HEPARIN SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 18, 2020
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
HEPARIN SODIUMActive
Quantity: 5000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
HEPARIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-542
Application NumberNDA017029
Product Classification
M
Marketing Category
C73594
G
Generic Name
HEPARIN SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 18, 2020
FDA Product Classification
INGREDIENTS (5)
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
HEPARIN SODIUMActive
Quantity: 10000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HEPARIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-915
Application NumberNDA017029
Product Classification
M
Marketing Category
C73594
G
Generic Name
HEPARIN SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 18, 2020
FDA Product Classification
INGREDIENTS (5)
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HEPARIN SODIUMActive
Quantity: 20000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
HEPARIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-276
Application NumberNDA017029
Product Classification
M
Marketing Category
C73594
G
Generic Name
HEPARIN SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 18, 2020
FDA Product Classification
INGREDIENTS (4)
HEPARIN SODIUMActive
Quantity: 1000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HEPARIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-459
Application NumberNDA017029
Product Classification
M
Marketing Category
C73594
G
Generic Name
HEPARIN SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 18, 2020
FDA Product Classification
INGREDIENTS (5)
BENZYL ALCOHOLInactive
Quantity: 10.42 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HEPARIN SODIUMActive
Quantity: 10000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM