Heparin Sodium
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
88114716-5759-4bc9-8a85-d28da12962cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2022
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
Products 7
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 Code67457-384
Application NumberANDA203851
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 11, 2019
FDA Product Classification
INGREDIENTS (6)
HEPARIN SODIUMActive
Quantity: 1000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 8.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10.4 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-603
Application NumberANDA203851
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 11, 2019
FDA Product Classification
INGREDIENTS (6)
HEPARIN SODIUMActive
Quantity: 10000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10.4 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-374
Application NumberANDA203851
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 11, 2019
FDA Product Classification
INGREDIENTS (6)
HEPARIN SODIUMActive
Quantity: 5000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10.4 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-383
Application NumberANDA203851
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 11, 2019
FDA Product Classification
INGREDIENTS (6)
HEPARIN SODIUMActive
Quantity: 5000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10.4 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-602
Application NumberANDA203851
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 11, 2019
FDA Product Classification
INGREDIENTS (6)
HEPARIN SODIUMActive
Quantity: 10000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10.4 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-385
Application NumberANDA203851
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 11, 2019
FDA Product Classification
INGREDIENTS (6)
BENZYL ALCOHOLInactive
Quantity: 10.4 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
HEPARIN SODIUMActive
Quantity: 1000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 8.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
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 Code67457-372
Application NumberANDA203851
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 11, 2019
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 8.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10.4 mg in 1 mL
Code: LKG8494WBH
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
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT