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
295ea9c6-d08c-40f0-a908-de0fdac44644
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2022
Manufacturers
FDA
BE Pharmaceuticals Inc.
DUNS: 081499296
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 Code71839-117
Application NumberANDA214804
Product Classification
M
Marketing Category
C73584
G
Generic Name
Heparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateApril 14, 2022
FDA Product Classification
INGREDIENTS (5)
HEPARIN SODIUMActive
Quantity: 2000 [USP'U] in 2 mL
Code: ZZ45AB24CA
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT