Anticoagulant Sodium Citrate

TRISODIUM CITRATE DIHYDRATE EXTRACORPOREAL HUMAN PRESCRIPTION DRUG

Anticoagulant Sodium Citrate is an FDA drug label for the active ingredient TRISODIUM CITRATE DIHYDRATE manufactured by LABORATORIOS GRIFOLS SA administered by EXTRACORPOREAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260414.

Generic name
TRISODIUM CITRATE DIHYDRATE
Manufacturer
LABORATORIOS GRIFOLS SA
Product type
HUMAN PRESCRIPTION DRUG
Route
EXTRACORPOREAL
Dosage form
N/A
NDC
76297-006
Application
BA125697
Label effective
20260414

About this product

Anticoagulant Sodium Citrate is an FDA-registered drug product whose active ingredient is TRISODIUM CITRATE DIHYDRATE. It is labelled by LABORATORIOS GRIFOLS SA taken by extracorporeal and marketed as a human prescription drug product. Identifiers on file: NDC 76297-006, application BA125697, label effective 20260414. It is one of 2 FDA drug label records sharing the active ingredient TRISODIUM CITRATE DIHYDRATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing TRISODIUM CITRATE DIHYDRATE are most often described in connection with: resultant solution, hes bag, usage tricitrasol, anticoagulant sodium, citrate concentrate, granulocytapheresis procedures, granulocyte collection, apheresis just. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Warnings

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.

More products with the same ingredient

TRISODIUM CITRATE DIHYDRATE

triCitrasol

Citra Labs LLC View label

How products containing TRISODIUM CITRATE DIHYDRATE compare

FDA lists 2 drug label records with TRISODIUM CITRATE DIHYDRATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Citra Labs LLC 1
— — LABORATORIOS GRIFOLS SA 1
— — — —
— — — —
— — — —

Recall and safety notices

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-1280-2022 Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-906-05 Nephron Sterile Compounding Center LLC Class II Terminated 20220727

Frequently asked questions

What is Anticoagulant Sodium Citrate used for?
The FDA label on file for this product does not include a full indications section. Other FDA labels sharing the active ingredient TRISODIUM CITRATE DIHYDRATE describe it in connection with: resultant solution, hes bag, usage tricitrasol, anticoagulant sodium, citrate concentrate, granulocytapheresis procedures, granulocyte collection, apheresis just. Check the specific product label or ask a prescriber before use.

Who makes Anticoagulant Sodium Citrate?
LABORATORIOS GRIFOLS SA is the labeler of record for Anticoagulant Sodium Citrate. 2 FDA label records share the active ingredient TRISODIUM CITRATE DIHYDRATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Anticoagulant Sodium Citrate come in?
administered by extracorporeal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Anticoagulant Sodium Citrate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing TRISODIUM CITRATE DIHYDRATE?
Yes. 2 FDA drug label records list TRISODIUM CITRATE DIHYDRATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Anticoagulant Sodium Citrate been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.