HEPARIN SODIUM
HEPARIN SODIUM INJECTION, USP 10,000 USP UNITS/mL 1mL VIAL
Approved
Approval ID
9bd0f982-30f4-4e38-e053-2a95a90a3e15
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2020
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
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 Code51662-1434
Application NumberANDA203198
Product Classification
M
Marketing Category
C73584
G
Generic Name
HEPARIN SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 22, 2020
FDA Product Classification
INGREDIENTS (6)
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HEPARIN SODIUMActive
Quantity: 10000 [USP'U] in 1 mL
Code: ZZ45AB24CA
Classification: ACTIM