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
ad0f410c-6121-43f9-9844-943472961cb0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2020
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
Products 1
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 Code71288-405
Application NumberANDA212060
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 31, 2020
FDA Product Classification
INGREDIENTS (4)
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
heparin sodiumActive
Quantity: 5000 [USP'U] in 0.5 mL
Code: ZZ45AB24CA
Classification: ACTIM
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT