Heparin sodium
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1939
Approved
Approval ID
e1ce1b9e-332b-4f1c-89c7-27071d3101ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2020
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-373
Application NumberANDA203852
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 (5)
HEPARIN SODIUMActive
Quantity: 20000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT