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 useInitial U.S. Approval: 1939
Approved
Approval ID
b6212d9b-d82b-46ea-9ba1-5410d04e0816
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2021
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
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 Code71288-421
Application NumberANDA211007
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
heparin sodiumActive
Quantity: 1000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
benzyl alcoholInactive
Quantity: 0.01 mL in 1 mL
Code: LKG8494WBH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
nitrogenInactive
Code: N762921K75
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 Code71288-420
Application NumberANDA211007
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
heparin sodiumActive
Quantity: 1000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
benzyl alcoholInactive
Quantity: 0.01 mL in 1 mL
Code: LKG8494WBH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
nitrogenInactive
Code: N762921K75
Classification: IACT
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-422
Application NumberANDA211007
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
heparin sodiumActive
Quantity: 5000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
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
waterInactive
Code: 059QF0KO0R
Classification: IACT
nitrogenInactive
Code: N762921K75
Classification: IACT
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-425
Application NumberANDA211007
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
heparin sodiumActive
Quantity: 10000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
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
nitrogenInactive
Code: N762921K75
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-424
Application NumberANDA211007
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
benzyl alcoholInactive
Quantity: 10.42 mg in 1 mL
Code: LKG8494WBH
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
waterInactive
Code: 059QF0KO0R
Classification: IACT
nitrogenInactive
Code: N762921K75
Classification: IACT
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-419
Application NumberANDA211007
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
benzyl alcoholInactive
Quantity: 0.01 mL in 1 mL
Code: LKG8494WBH
Classification: IACT
heparin sodiumActive
Quantity: 1000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
nitrogenInactive
Code: N762921K75
Classification: IACT
Heparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-423
Application NumberANDA211007
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
heparin sodiumActive
Quantity: 5000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
benzyl alcoholInactive
Quantity: 10.42 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
nitrogenInactive
Code: N762921K75
Classification: IACT