Heparin Sodium
Heparin Sodium Injection, USP These highlights do not include all the information needed to use HEPARIN SODIUM INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM INJECTION. HEPARIN SODIUM injection, for intravenous or subcutaneous use Initial U.S. Approval: 1939
Approved
Approval ID
7f05762a-7527-4796-b21e-68277aec379e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2023
Manufacturers
FDA
McKesson Corporation dba SKY Packaging
DUNS: 140529962
Products 9
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 Code63739-920
Application NumberANDA202957
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (7)
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
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 Code63739-953
Application NumberANDA202957
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (7)
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
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 Code63739-901
Application NumberANDA202733
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (6)
BENZYL ALCOHOLInactive
Quantity: 15 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
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 Code63739-986
Application NumberANDA203198
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateAugust 30, 2023
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HEPARIN SODIUMActive
Quantity: 20000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63739-964
Application NumberANDA203198
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (6)
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HEPARIN SODIUMActive
Quantity: 10000 [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
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63739-975
Application NumberANDA203198
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (6)
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HEPARIN SODIUMActive
Quantity: 10000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63739-900
Application NumberANDA202732
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
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 Code63739-931
Application NumberANDA202957
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
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 Code63739-942
Application NumberANDA202957
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (7)
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HEPARIN SODIUMActive
Quantity: 1000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT