Haemonetics Anticoagulant Sodium Citrate
Haemonetics Anticoagulant Sodium Citrate
Approved
Approval ID
447528e6-55cd-4a9b-868e-2a741b2693d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2021
Manufacturers
FDA
Haemonetics Corporation
DUNS: 057827420
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TRISODIUM CITRATE DIHYDRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57826-420
Application NumberBN980123
Product Classification
M
Marketing Category
C73594
G
Generic Name
TRISODIUM CITRATE DIHYDRATE
Product Specifications
Route of AdministrationEXTRACORPOREAL
Effective DateFebruary 2, 2021
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEActive
Quantity: 40 mg in 1 mL
Code: B22547B95K
Classification: ACTIM
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 10/25/2017
Product Labeling
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 10/25/2017
STERILE, nonpyrogenic fluid path.
WARNINGS SECTION
LOINC: 34071-1Updated: 1/10/2013
CAUTION:
Not for direct intravenous infusion. The pouch is a moisture barrier. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion.
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 10/25/2017
RECOMMENDED STORAGE:
Room temperature (25°C/77°F). Avoid excess heat. Protect from freezing.
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 10/25/2017
Product code
Product Code 420A
117881-00, Rev. AA-XXX
Haemonetics Corporation
400 Wood Road
Braintree, MA 02184 USA